510(k) pre-market notification project

Osteova, Inc. WedgeX™ Bone Wedge

510(k) Premarket Notification

Traditional 510(k)

Prepared by Group 5

Vanessa Chua

Sneha Iyer

Moon Jiao

Brandon MacAleese

Nitya Ramesh

Herman Tsang (correspondent)

Osteova, Inc.

WedgeX™ Bone Wedge

Traditional 510(k)

Confidential

Table of Contents

Screening Checklist .................................................................................................................................... 7

Section 1 – Medical Device User Fee Cover Sheet (Form FDA 3601) ....................................................... 8

Section 2 – CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) ................................... 9

Section 3 – 510(k) Cover Letter ................................................................................................................ 16

Section 4 – Indications for Use Statement ................................................................................................ 17

Section 5 – 510(k) Summary .................................................................................................................... 18

5.1 Device Description.......................................................................................................................... 18

5.2 Intended Use ................................................................................................................................... 19

5.3 Substantial Equivalence .................................................................................................................. 19

5.4 Technological Characteristics ......................................................................................................... 19

5.5 Performance Data............................................................................................................................ 19

Section 6 – Truthful and Accurate Statement............................................................................................ 20

Section 7 – Class III Summary and Certification ...................................................................................... 21

Section 8 – Financial Certification or Disclosure Statement (Forms FDA 3454 and 3455) ...................... 22

Section 9 – Declarations of Conformity and Summary Reports (Form FDA 3654) .................................. 23

Section 10 – Executive Summary ............................................................................................................. 24

10.1 Description of Device ................................................................................................................... 24

10.2 Technology ................................................................................................................................... 24

10.3 Indications for Use ........................................................................................................................ 24

10.4 Substantial Equivalence ................................................................................................................ 25

Table 1: Device Comparison ............................................................................................................ 25

10.5 Summary of Performance Testing ................................................................................................. 26

Osteova, Inc.


Traditional 510(k)

Confidential

Table 2: Biocompatibility Testing ..................................................................................................... 26

Table 3: Bench Testing ..................................................................................................................... 26

Section 11 – Device Description ............................................................................................................... 27

11.1 Description of the Device.............................................................................................................. 27

Figure 1: Engineering drawing for the WedgeX™ Bone Wedge for an Evans Procedure. There are

three holes for bone grafting material or biologics and a single hole for interfacing with the

installation tool. ................................................................................................................................ 28

Figure 2: Engineering drawing for the WedgeX™ Bone Wedge for a Cotton Osteotomy. There are

two holes provided for bone grafting material or biologics. ............................................................. 28

11.2 Technology ................................................................................................................................... 29

Table 4: Available WedgeX™ Sizes for use in an Evans Procedure or other similar opening wedge

procedure. Note: The thickness of each sizing tool is etched onto the tool........................................ 29

Table 5: Available WedgeX™ Sizes for use in a Cotton Osteotomy or other similar opening wedge

procedure. Note: The thickness of each sizing tool is etched onto the tool........................................ 29

11.3 Indication for Use ......................................................................................................................... 30

11.4 Device Packaging.......................................................................................................................... 30

I. Pouch ............................................................................................................................................. 30

II. Dispenser Box .............................................................................................................................. 30

III. Outer Carton ............................................................................................................................... 30

Table 6: Device packaging validation activities ............................................................................... 31

Section 12 – Substantial Equivalence Discussion ..................................................................................... 32

Table 7: Predicate Device ................................................................................................................. 32

Table 8: Device Comparison ............................................................................................................ 33

Table 9: SE Determination................................................................................................................ 34

Section 13 – Proposed Labeling ................................................................................................................ 36

Osteova, Inc.


Traditional 510(k)

Confidential

13.1 Labeling Description and Figures ................................................................................................. 36

Figure 3: Patient ID Label ................................................................................................................ 36

Figure 4: Printed Tyvek® Pouch ....................................................................................................... 37

Figure 5: Dispenser Box Printed Design .......................................................................................... 37

Figure 6: Outer Carton Label ........................................................................................................... 38

Figure 7: Outer Carton Printed Design ............................................................................................ 38

13.2 Package Insert ............................................................................................................................... 39

I. General Product Information ......................................................................................................... 39

II. Device Description ....................................................................................................................... 39

III. Indications for Use ...................................................................................................................... 40

IV. Contraindications ........................................................................................................................ 40

V. Cautions ....................................................................................................................................... 40

VI. Precautions.................................................................................................................................. 40

VII. Adverse Events .......................................................................................................................... 41

VIII. Packaging, Sterilization, and Storage ....................................................................................... 41

IX. Surgical Techniques .................................................................................................................... 42

X. Patient Population ........................................................................................................................ 42

XI. Life of Device ............................................................................................................................. 42

XII. Symbols Used on Packaging ..................................................................................................... 42

XIII. Contact Information ................................................................................................................. 43

Section 14 – Sterilization and Shelf Life................................................................................................... 44

14.1 Ethylene Oxide (EO) Sterilization ................................................................................................ 44

14.2 Shelf Life ...................................................................................................................................... 44

Osteova, Inc.


Traditional 510(k)

Confidential

Section 15 – Biocompatibility ................................................................................................................... 45

15.1 General Description ...................................................................................................................... 45

Table 10: Biocompatibility Testing ................................................................................................... 45

15.2 Test Details ................................................................................................................................... 46

I. Cytotoxicity ................................................................................................................................... 46

II. Sensitization ................................................................................................................................. 46

III. Skin Irritation .............................................................................................................................. 46

IV. Acute Systemic Toxicity and Sub-acute/Sub-chronic Toxicity ................................................... 47

V. Genotoxicity ................................................................................................................................. 47

VI. Implantation ................................................................................................................................ 47

VII. Carcinogenicity ......................................................................................................................... 47

15.3 Conclusion .................................................................................................................................... 47

Section 16 – Software ............................................................................................................................... 48

Section 17 – Electromagnetic Compatibility and Electrical Safety ........................................................... 49

Section 18 – Performance Testing: Bench ................................................................................................ 50

Table 11: Bench Testing ................................................................................................................... 50

I. Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices, ASTM F2077-11 .... 50

Figure 8: Static and Fatigue Testing Instrument. ............................................................................. 50

II. Axial and Torsion Testing of Bone Screws, ASTM F543 ............................................................ 51

III. Flexural Fatigue Testing Metallic Bone Plates, ASTM F382-99................................................. 52

Figure 9: Flexural Fatigue Testing Instrument. ................................................................................ 52

IV. Spinal Constructs – Static, Torsion, and Fatigue Testing, ASTM F1717 .................................... 52

Section 19 – Performance Testing: Animal............................................................................................... 53

Osteova, Inc.


Traditional 510(k)

Confidential

Section 20 – Performance Testing: Clinical .............................................................................................. 54

Section 21 – List of Referenced Standards and Guidance Documents ...................................................... 55

Osteova, Inc.


Traditional 510(k)

Confidential

Screening Checklist

Section Title Present N/A

1 Medical Device User Fee Cover Sheet (Form FDA 3601) X

2 CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) X

3 510(k) Cover Letter X

4 Indications for Use Statement X

5 510(k) Summary or 510(k) Statement X

6 Truthful and Accurate Statement X

7 Class III Summary and Certification X

8 Financial Certification or Disclosure Statement (Forms FDA 3454 and 3455) X

9 Declarations of Conformity and Summary Reports (Form FDA 3654) X

10 Executive Summary X

11 Device Description X

12 Substantial Equivalence Discussion X

13 Proposed Labeling X

14 Sterilization and Shelf Life X

15 Biocompatibility X

16 Software X

17 Electromagnetic Compatibility and Electrical Safety X

18 Performance Testing – Bench X

19 Performance Testing – Animal X

20 Performance Testing – Clinical X

21 List of Referenced Standards and Guidance Documents X

Osteova, Inc.


Traditional 510(k)

Confidential

Section 1 – Medical Device User Fee Cover Sheet (Form FDA 3601)

Osteova, Inc.


Traditional 510(k)

Confidential

Section 2 – CDRH Premarket Review Submission Cover Sheet (Form FDA

3514)

Osteova, Inc.


Traditional 510(k)

Confidential

Osteova, Inc.


Traditional 510(k)

Confidential

Section 3 – 510(k) Cover Letter

Food and Drug Administration

Center for Devices and Radiological Health

510(k) Document Mail Center (HFZ-401)

9200 Corporate Boulevard

Rockville, Maryland 20850

Re: Osteova, Inc.

WedgeX™ Bone Wedge Traditional 510(k) Submission

To whom it may concern:

I am submitting the following premarket notification for Osteova, Inc. of Los Angeles, California to

obtain FDA clearance to market the WedgeX™ Bone Wedge. One of the two copies of this submission

will be an electronic copy. The device is a class II device under 21 CFR 888.3030, titled bone fixation

plate. The device currently falls under product code HRS under the orthopedic device panel review.

The WedgeX™ Bone Wedge is substantially equivalent to the BIOFOAM® Bone Wedge (Wright

Medical Technology, Inc. under K140531) cleared by FDA on July 9th, 2014. The WedgeX™ Bone

Wedge does not incorporate any new technological characteristics, as compared to the predicate device.

Osteova, Inc. considers the information contained in this submission to be proprietary and not intended

for public disclosure, except for the 510(k) summary. Confidentiality is requested in accordance with 21

CFR 807.95.

To address inquiries or concerns, please contact the correspondent, Herman Tsang, at 213-123-4567 or by

email at [email protected].

Sincerely,

Herman Tsang

Director of Regulatory Affairs

Osteova, Inc.

123 Sample Street

Los Angeles

CA 90089

[email protected]

mailto:[email protected]

mailto:[email protected]

Osteova, Inc.


Traditional 510(k)

Confidential

Section 4 – Indications for Use Statement

Osteova, Inc.


Traditional 510(k)

Confidential

Section 5 – 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical

Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of

Safety and Effectiveness for the use of the WedgeX™ Bone Wedge.

Submitted by: Osteova, Inc.

123 Sample Street

Los Angeles, CA 90089

Date: November 22, 2014

Contact Person: Herman Tsang

Director of Regulatory Affairs

[email protected]

Proprietary Name: WedgeX™ Bone Wedge

Common Name: Plate, bone fixation; bone wedge (for foot)

Classification Name and Reference: 21 CFR 888.3030, Class II

Device Product Code, Device Panel: HRS, Orthopedic

Predicate Device: BIOFOAM® Bone Wedge (K140531)

5.1 Device Description

WedgeX™ Bone Wedge is a foot-bone wedge that is surgically inserted into an osteotomy void and then

secured with an ancillary fixation that is compatible with various products by Osteova, Inc. The device is

used in procedures for mechanically realigning bones in the foot. The device’s structure is designed to

mimic the porosity of bone matter to facilitate its ingrowth and incorporation after its insertion into the

void. The device is made of a titanium metal foam. It is offered in two styles and a variety of widths and

thicknesses in order to accommodate different osteotomy procedures in the foot. The accessories of this device include the ancillary fixation and screws. The ancillary fixation prevents

the wedge from becoming dislodged after insertion, and the screws secure the fixation in place. Although

the ancillary fixation and screws are not included in the package for WedgeX™ Bone Wedge, they can be

purchased separately and are compatible with the wedge and other products by Osteova, Inc. In addition

to the ancillary fixation and screws, required accessories that can be purchased separately for installing

the WedgeX™ device include void sizing tools to aid in determining the depth and thickness of the void,

and handles to assist with the placement of the device.

WedgeX™ is provided sterile and non-pyrogenic. There are multiple locations where bone-grafting

material or biologics may be applied by the physician.

Osteova, Inc.


Traditional 510(k)

Confidential

5.2 Intended Use

The WedgeX™ Bone Wedge is indicated for internal bone fixation for bone fractures, fusions, or

osteotomies in the ankle and foot, such as opening wedge osteotomies of the bones of the foot including

Hallux Valgus; opening wedge of Medial Cuneiform or Cotton osteotomies; Lateral Column

Lengthening; Metatarsal/Cuneiform arthrodesis; opening wedge osteotomies of the bones of the foot

including osteotomies for Hallux Valgus; and nonunion of arthrodesis of the Midfoot including

Metatarsal Cuneiform arthrodesis. This device is indicated for use with ancillary fixation. This device is

provided sterile. This device is for prescription use only. The WedgeX™ Bone Wedge is not indicated for

use in the spine. The safety and effectiveness of the WedgeX™ Bone Wedge have not been established in

children, adolescents, or those who are pregnant or may become pregnant.

5.3 Substantial Equivalence

WedgeX™ Bone Wedge is substantially equivalent to the predicate, BIOFOAM® Bone Wedge. The

devices have the same indications for use, are made of the same material, and are sterilized with

acceptable methods. Testing rationale was provided to support the equivalence of the WedgeX™ Bone Wedge and shows that

no new questions of safety and effectiveness have been introduced with this device. The safety and

effectiveness of the WedgeX™ Bone Wedge are adequately supported by the testing rationale, substantial

equivalence information, materials information, and comparison of design characteristics provided within

this premarket notification.

5.4 Technological Characteristics

The WedgeX™ Bone Wedge is technologically substantially equivalent to the predicate device. Both

devices are identical in material.

5.5 Performance Data

The materials used in the manufacture of the WedgeX™ Bone Wedge are identical to those used in the

predicate device. The major material is titanium. The device passed all biocompatibility tests. In accordance to ISO 10993-1:2009 and FDA G95-1

guidelines, the following biocompatibility tests were performed: Cytotoxicity, Sensitization,

Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity, and

Implantation. The performance bench tests include Conformational Structure Analysis; Static, Torsion, and Fatigue

Testing; Flexural Fatigue Testing Metallic Bone Plates; Axial and Torsion Testing of Bone Screws; and

Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices. WedgeX™ Bone Wedge

passed the performance tests and thus has structural integrity comparable to that of the predicate’s.

Sterilization by ethylene oxide has been validated for WedgeX™ Bone Wedge.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 6 – Truthful and Accurate Statement

I, Herman Tsang certify that, in my capacity as Director of Regulatory Affairs of Osteova, Inc., I believe

to the best of my knowledge, that all data and information submitted in the premarket notification are

truthful and accurate and that no material fact has been omitted.

Herman Tsang (Signature)

Herman Tsang

(Typed Name)

November 22, 2014

(Date)

_______________________________

*(Premarket Notification [510(k)] Number)

*For a new submission, leave the 510(k) number blank.

Must be signed by a responsible person of the firm required to submit the premarket notification [e.g., not

a consultant for the 510(k) submitter].

Osteova, Inc.


Traditional 510(k)

Confidential

Section 7 – Class III Summary and Certification

WedgeX™ Bone Wedge is classified as a Class II device. Therefore, Class III Summary and Certification

is does not required for this device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 8 – Financial Certification or Disclosure Statement (Forms FDA 3454

and 3455)

No clinical studies were performed with WedgeX™ Bone Wedge. Therefore, Financial Certification of

Disclosure Statement is not required for this device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 9 – Declarations of Conformity and Summary Reports (Form FDA

3654)

Declarations of Conformity and Summary Reports is not required for a Traditional 510(k).

Osteova, Inc.


Traditional 510(k)

Confidential

Section 10 – Executive Summary

10.1 Description of Device












and handles to assist with the placement of the device. WedgeX™ is provided sterile and non-pyrogenic. There are multiple locations where bone-grafting

material or biologics may be applied by the physician, as shown in Figures 1 and 2 in Section 11 –

Description of the Device.

10.2 Technology

The WedgeX™ Bone Wedge is a sterilized, titanium metal foam wedge. Titanium is widely used for a

variety of biomedical implantation devices. Titanium is known for its strength and biocompatibility.

WedgeX™ includes multiple locations where either bone-grafting material may be applied to facilitate

natural bone growth after installation, or where biologics may be applied per discretion of the physician.

The rough surface of the wedge allows for a high coefficient of friction between the wedge and the bones

surrounding it, aiding to keep the wedge in place. WedgeX™ comes in two styles and a variety of widths and thicknesses in order to accommodate different

osteotomy procedures in the foot. The sizing tools described in Section 11.1, Description of the Device,

are color-coded for ease of identification.

10.3 Indications for Use










Osteova, Inc.


Traditional 510(k)

Confidential

10.4 Substantial Equivalence

Osteova, Inc. believes the WedgeX™ Bone Wedge to be substantially equivalent to its predicate.

Comparisons of the devices are tabulated below in Table 1 and also in Table 9 of Section 12 – Substantial

Equivalence Discussion.

Table 1: Device Comparison

Device BIOFOAM® Bone Wedge (Predicate) WedgeX™ Bone Wedge

Design Two styles and a variety of widths and

thicknesses. The accessories include

the ancillary fixation and screws.

One style and a variety of widths and

thicknesses. The accessories include the

ancillary fixation and screws.

Materials Titanium metal foam Titanium metal foam

Intended use The BIOFOAM® Bone Wedge is

indicated for internal bone fixation for

bone fractures, fusions, or osteotomies

in the ankle and foot, such as opening

wedge osteotomies of the bones of the

foot including Hallux Valgus; opening

wedge of Medial Cuneiform or Cotton

osteotomies; Lateral Column

Lengthening; Metatarsal/Cuneiform

arthrodesis; opening wedge

osteotomies of the bones of the foot

including osteotomies for Hallux

Valgus; and nonunion of arthrodesis of

the Midfoot including Metatarsal

Cuneiform arthrodesis. This device is

indicated for use with ancillary

fixation. This device is provided

sterile. This device is for prescription

use only. The BIOFOAM® Bone

Wedge is not indicated for use in the

spine. The safety and effectiveness of

the BIOFOAM® Bone Wedge have not

been established in children,

adolescents, or those who are pregnant

or may become pregnant.

The WedgeX™ Bone Wedge is









arthrodesis; opening wedge osteotomies

of the bones of the foot including

osteotomies for Hallux Valgus; and

nonunion of arthrodesis of the Midfoot

including Metatarsal Cuneiform

arthrodesis. This device is indicated for

use with ancillary fixation. This device

is provided sterile. This device is for

prescription use only. The WedgeX™

Bone Wedge is not indicated for use in

the spine. The safety and effectiveness

of the WedgeX™ Bone Wedge have not




Size availability Two orientations and fifteen sizes Two orientations and twenty-one sizes

Anatomical Site Below the sinus tarsi, extending

proximal to the calcaneocuboid joint

Below the sinus tarsi, extending


Sterilization Provided sterile, unknown method Ethylene oxide

510(K) Number K140531 TBD

Osteova, Inc.


Traditional 510(k)

Confidential

10.5 Summary of Performance Testing

WedgeX™ Bone Wedge was subjected to thorough biocompatibility and mechanical testing.

Performance Testing includes the biocompatibility tests and bench tests. Detailed descriptions of the

biocompatibility tests and bench tests are presented in Sections 15 and 18, respectively. WedgeX™ Bone

Wedge passed all the performance tests. Therefore, we conclude that it is substantially equivalent to its

predicate. Table 10 of Section – 15 Biocompatibility summarizes the tests performed, methods employed,

and results obtained (shown below in Table 2). Table 11 of Section 18 – Performance Testing: Bench

summarizes the performance bench tests that were performed with this device (shown below in Table 3).

Table 2: Biocompatibility Testing

Test Method Test

Sample

Animal Standard Result

Cytotoxicity MEM Test Leachate Cellular ISO-10993-

5:2009

Pass

Sensitization Maximization Leachate Guinea Pig ISO-10993-

10:2013

Pass

Irritation/Intracutaneous

Reactivity

Rabbit

Intracutaneous

Reactivity Test

Leachate

Rabbit

ISO-10993-

10:2013

Pass

Acute Systemic

Toxicity

Mouse Systemic

Injection

Leachate Mouse ISO-10993-

11:2009

Pass

Sub-chronic Toxicity Mouse Systemic

Injection


11:2009

Pass

Genotoxicity Ames Reverse

Mutation

Leachate S. typhimurium ISO-10993-

3:2009

Pass

Implantation Implantation Test Leachate Rabbit ISO-10993-

6:2009

Pass

Table 3: Bench Testing

Test Test Method Result Status

Conformational Structure

Analysis

FEM

(Finite Element Method

Testing)

TBD Pass

Static, Torsion and Fatigue

Testing

ASTM F1717* As per manufacturing

specifications

Pass

Flexural Fatigue Testing

Metallic Bone Plates

ASTM F382-99 As per manufacturing

specifications

Pass

Axial and Torsion Testing of

Bone Screws

ASTM F543 As per manufacturing

specifications

Pass

Characterization and Fatigue

of Spinal Intervertebral Body

Fusion Devices

ASTM F2077 – 11*

As per manufacturing

specifications

Pass

*Although ASTM F2077-11 and ASTM F1717 are written for spinal implants, the same basic methods

outlined in these standards may be applied for testing of other bone implants such as the WedgeX™ Bone

Wedge.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 11 – Device Description

11.1 Description of the Device













material or biologics may be applied by the physician, as shown in Figure 1 and Figure 2 below.

Osteova, Inc.


Traditional 510(k)

Confidential

Figure 1: Engineering drawing for the WedgeX™ Bone Wedge for an Evans Procedure. There are

three holes for bone grafting material or biologics and a single hole for interfacing with the

installation tool.

Figure 2: Engineering drawing for the WedgeX™ Bone Wedge for a Cotton Osteotomy. There are two

holes provided for bone grafting material or biologics.

Osteova, Inc.


Traditional 510(k)

Confidential

11.2 Technology

The WedgeX™ Bone Wedge is a sterilized, titanium metal foam wedge. Titanium is widely used for a

variety of biomedical implantation devices. Titanium is known for its strength and biocompatibility.

WedgeX™ has multiple locations that allow for either bone-grafting material to be applied to facilitate

natural bone growth after installation, or for biologics to be applied per discretion of the physician. The

rough surface of the wedge allows for a high coefficient of friction between the wedge and the bones

surrounding it, aiding to keep the wedge in place. WedgeX™ comes in two styles and a variety of widths and thicknesses in order to accommodate different

osteotomy procedures in the foot. The sizing tools mentioned above in Section 11.1, Description of the

Device, are color-coded for ease of identification. Tables 4 and 5, below, outline the different dimensions

for the two different styles of bone wedges:

Table 4: Available WedgeX™ Sizes for use in an Evans Procedure or other similar opening wedge

procedure. Note: The thickness of each sizing tool is etched onto the tool.

Part Number Color Indicator for

Sizing Tools Width x Depth (mm) Thickness (mm)

WXEP16-08 Red ■ 16x16 8

WXEP16-10 Red ■ 16x16 10

WXEP16-12 Red ■ 16x16 12

WXEP18-08 Orange ■ 18x18 8



WXEP20-08 Gold ■ 20x20 8

WXEP20-10 Gold ■ 20x20 10

WXEP20-12 Gold ■ 20x20 12

WXEP22-08 Green ■ 22x22 8

WXEP22-10 Green ■ 22x22 10

WXEP22-12 Green ■ 22x22 12

Table 5: Available WedgeX™ Sizes for use in a Cotton Osteotomy or other similar opening wedge

procedure. Note: The thickness of each sizing tool is etched onto the tool.

Part Number Color Indicator for

Sizing Tools

Length

(mm)

Dorsal

Width (mm)

Plantar Width

(mm)

Thickness (mm)

WXCO16-45 Blue ■ 16 14 10 4.5

WXCO16-55 Blue ■ 16 14 10 5.5

WXCO16-65 Blue ■ 16 14 10 6.5

WXCO18-45 Purple ■ 18 14 10 4.5

WXCO18-55 Purple ■ 18 14 10 5.5

WXCO18-65 Purple ■ 18 14 10 6.5

WXCO20-45 Black ■ 20 14 10 4.5

WXCO20-55 Black ■ 20 14 10 5.5

WXCO20-65 Black ■ 20 14 10 6.5

Osteova, Inc.


Traditional 510(k)

Confidential

11.3 Indication for Use










11.4 Device Packaging

I. Pouch

WedgeX™ is placed inside a Tyvek® pouch with a high-barrier foil backing. Using a high-barrier foil

pouch mitigates the risk of the titanium-foam bone wedge damaging the pouch. An adhesive label

containing three removable labels for patient medical files is adhered to the back foil-side of the pouch.

The proposed information for the patient ID labels is given in Figure 3.

The device is for single use only. The Tyvek® pouch is pre-printed with the proposed labeling given in

Figure 4. The pouch can be peeled open via the chevron-style seal (directions given) when the device is to

be used. The pouch is compatible for ethylene oxide sterilization. It has consistent peel strength and

adequate seal integrity according to ASTM F1886/F1886M - Standard Test Method for Determining

Integrity of Seals for Flexible Packaging by Visual Inspection. Once the device is packaged in the pouch,

it is packaged in a paperboard dispenser box and then in a corrugate box.

II. Dispenser Box

After being sealed in the pouch, WedgeX™ is placed inside a small dispenser box. The box is stored in a

surgical environment and features a perforated window that can be torn away to allow for quick retrieval

prior to a procedure. The dispenser box is made of paperboard and is printed with corporate identity and

product identification information on four sides, excluding the top and bottom. The proposed printing is

shown in Figure 5.

III. Outer Carton

Four dispenser boxes are packaged into a single outer carton, which is sent to be sterilized by ethylene

oxide according to the standards in AAMI/ANSI/ISO 11135 Standards: Sterilization of health care

products - Ethylene oxide. The outer carton is made of cardboard that is not sterile. It follows the ISO

Standard 11607: Packaging for terminally sterilized medical devices. The outer carton is labeled on one

end and is printed with the corporate identity on four sides, excluding the top and bottom. The proposed

labeling and carton printing are given in Figure 6 and Figure 7, respectively.

Osteova, Inc.


Traditional 510(k)

Confidential

See Table 6 below for a summary of the different validation activities that were completed for the

packaging of the device.

Table 6: Device packaging validation activities

Test Name Reason(s) for Testing Standards Tested Vibration Simulate the vibrations that could

normally be experienced by the

device during transportation to

evaluate the effects it may have on

the packaging from the outer

carton to the device pouch.

ASTM D4728: Test Method for Random

Vibration Testing of Shipping Containers

Drop/Shock Simulate the potential hazard of

the device being dropped from

specific heights to determine if the

packaging (cartons) adequately

protects the contents within,

preventing damage to the device

and pouch.

ASTM D5276: Test Method for Drop Test

of Loaded Containers by Free Fall

Sterility To ensure that the device is sterile

after undergoing ethylene oxide

sterilization.

To ensure that EO residuals are

properly outgassed from the

device.

ISO 11737-2: Sterilization of medical

devices - Microbiological methods - Part 2:

Tests of sterility performed in the

definition, validation and maintenance of a

sterilization process

EN 556: Sterilization of medical devices -

Requirements for medical devices to be

designated "STERILE" - Part 1:

Requirements for terminally sterilized

medical devices

ISO11135-1: Sterilization of health care

products - Ethylene oxide - Part 1:

Requirements for development, validation

and routine control of a sterilization

process for medical devices.

ISO 10933-7: Biological evaluation of

medical devices - Part 7: Ethylene oxide

sterilization residuals.

Pouch Integrity To evaluate the strength of the

pouch seal at multiple points

around the seal and determine if

there are any pinholes in the

Tyvek® or voids in the seal.

ASTM F88/F88M: Standard Test Method

for Seal Strength of Flexible Barrier

Materials

Biocompatibility To determine that the packaging of

the device does not have any

adverse effects on the

biocompatibility of the device.

ASTM F2475 – 05: Standard Guide for

Biocompatibility Evaluation of Medical

Device Packaging Materials

Osteova, Inc.


Traditional 510(k)

Confidential

Section 12 – Substantial Equivalence Discussion

Date of preparation November 22, 2014

Trade name WedgeX™ Bone Wedge

Common name Osteotomy Bone Wedge

Classification name Plate, bone fixation; bone wedge (for foot)

Device classification Class II

Product classification 888.3030

Product code HRS

Classification panel Orthopedic devices

Establishment Registration Number TBD

Substantially Equivalent to the predicate described in Table 7: Predicate Device

Table 7: Predicate Device

Predicate device Model number 510(k) number 510(k) holder Clearance date

BIOFOAM® Bone

Wedge

135765-3 K140531 Wright Medical

Technology, Inc.

July 9, 2014


secured with an ancillary fixation. The device is used in procedures for mechanically realigning bones in

the foot.

For purposes of this submission, WedgeX™ Bone Wedge was compared to BIOFOAM® Bone Wedge. A

detailed comparison is given below in Table 8: Device Comparison, and the process of determination of

substantial equivalence is given below in Table 9: SE Determination.

Osteova, Inc.


Traditional 510(k)

Confidential

Table 8: Device Comparison

Device BIOFOAM® Bone Wedge (Predicate) WedgeX™ Bone Wedge

Design Two styles and a variety of widths and

thicknesses. The separate accessories

include the ancillary fixation and

screws.

One style and a variety of widths and

thicknesses. The separate accessories

include the ancillary fixation and

screws.

Materials Titanium metal foam Titanium metal foam

Intended use The BIOFOAM® Bone Wedge is









arthrodesis; opening wedge

osteotomies of the bones of the foot

including osteotomies for Hallux

Valgus; and nonunion of arthrodesis of

the Midfoot including Metatarsal

Cuneiform arthrodesis. This device is

indicated for use with ancillary

fixation. This device is provided

sterile. This device is for prescription

use only. The BIOFOAM® Bone

Wedge is not indicated for use in the

spine. The safety and effectiveness of

the BIOFOAM® Bone Wedge have not




The WedgeX™ Bone Wedge is









arthrodesis; opening wedge osteotomies

of the bones of the foot including

osteotomies for Hallux Valgus; and

nonunion of arthrodesis of the Midfoot

including Metatarsal Cuneiform

arthrodesis. This device is indicated for

use with ancillary fixation. This device

is provided sterile. This device is for

prescription use only. The WedgeX™

Bone Wedge is not indicated for use in

the spine. The safety and effectiveness

of the WedgeX™ Bone Wedge have not




Size availability Two orientations and fifteen sizes Two orientations and twenty-one sizes

Anatomical Site Below the sinus tarsi, extending


Below the sinus tarsi, extending


Sterilization Provided sterile, unknown method Ethylene oxide

510(K) Number K140531 TBD

Osteova, Inc.


Traditional 510(k)

Confidential

Table 9: SE Determination

Questions Answers BIOFOAM® Bone Wedge WedgeX™ Bone Wedge

Is the predicate device

legally marketed?

Yes Wright Medical

Technology, Inc.

K140531

Osteova, Inc.

Do the devices have

the same intended use?

Yes The BIOFOAM® Bone

Wedge is indicated for

internal bone fixation

The WedgeX™ Bone

Wedge is indicated for

internal bone fixation

Do the devices have

the same technological

characteristics?

Yes Design:

Two styles, a variety of

widths and thicknesses, with

accessories purchased and

packaged separately

Material characteristics:

High coefficient of friction

Porosity of the

osteoconductive matrix

Biocompatible

Sterile

Design:

Two styles, a variety of

widths and thicknesses, with

accessories purchased and

packaged separately

Material characteristics:

High coefficient of friction

Porosity of the

osteoconductive matrix

Biocompatible

Sterile

No Fifteen sizes available Twenty-one sizes available

Do the different

technological

characteristics of the

devices raise different

questions of safety and

effectiveness?

No Biocompatibility and

performance testing were

conducted, and the results do

not raise any new questions

of safety or effectiveness.

Biocompatibility and

performance testing were

conducted, and the results do

not raise any new questions

of safety or effectiveness.

Are the methods

acceptable, and do the

data demonstrate

substantial

equivalence?

Yes The methods are acceptable,

and the data demonstrate

substantial equivalence.

The methods are acceptable,

and the data demonstrate

substantial equivalence.

Osteova, Inc.


Traditional 510(k)

Confidential

Conclusion

The characteristics of WedgeX™ Bone Wedge are identical to those of the predicate device in almost all

categories. The device has the same intended use as its predicate. Because it is composed of the same

materials, the device is biocompatible, like its predicate. Also, packaging and labeling of the device are

the same as those of its predicate. Much like its predicate, the device requires the use of special

accessories, such as ancillary fixation and screws that prevent the wedge from becoming dislodged after

insertion and that secure the fixation in place, and different tools for sizing and handling of the device.

These accessories are purchased and packaged separate from WedgeX™ Bone Wedge. Compared to BIOFOAM® Bone Wedge, WedgeX™ Bone Wedge comes in a larger range of sizes to

accommodate various operative procedures. However, WedgeX™ Bone Wedge passed biocompatibility

and performance tests that are discussed in Section 15 and Section 18 and hence is as safe as its predicate. Based on the comparison to its predicate, we conclude that the design characteristics of WedgeX™ Bone

Wedge do not raise any new questions of safety or effectiveness. Therefore, we conclude that it is

substantially equivalent to its previously cleared predicate.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 13 – Proposed Labeling

13.1 Labeling Description and Figures

WedgeX™ comes with labels for patient medical files, an outer carton label, printed Tyvek® pouches

with device information, and a package insert inside a plastic sleeve that is adhered to each dispenser box.

The labels for patient medical files are printed with basic device information and have fields for patient

information to be filled out by the physician. These labels are detached from the adhesive label and are

placed in a patient’s medical file. The outer carton label and printed Tyvek® pouches display information

about the WedgeX™ bone wedge. The package insert contains detailed information regarding the device

including a description, caution statement(s), indications/contraindications, explanation of any symbols

used, etc. as explained in Section 13.2, Package Insert. The proposed designs for the patient ID labels,

printed Tyvek® pouch, outer carton label, and printed boxes are shown in the following figures.

WedgeX™ has a shelf life expiration date of 5 years and is labeled accordingly on the pouch printing and

the outer carton label. The device may be used up until the last day of the month that is shown on the

labeling.

Figure 3: Patient ID Label

Osteova, Inc.


Traditional 510(k)

Confidential

Figure 4: Printed Tyvek® Pouch

Figure 5: Dispenser Box Printed Design

Osteova, Inc.


Traditional 510(k)

Confidential

Figure 6: Outer Carton Label

Figure 7: Outer Carton Printed Design

Osteova, Inc.


Traditional 510(k)

Confidential

13.2 Package Insert

I. General Product Information

The device provided is to be used for correcting deformities in foot structure and reducing pain for many

patients. Although widely recognized as a successful treatment method for these procedures, the implants

are manufactured from metal and so cannot be expected to perform as well as normal, healthy bone after

fusion occurs. Evaluation of the risks/benefits associated with the use of this device must be performed by the surgeon.

As implantation of the WedgeX™ Bone Wedge will facilitate bone fusion post-operatively, the surgeon

must consider the following:

● The initial sizing of the required implant is critical to the effectiveness of the device. ● Patient occupation can affect the device, ancillary fixation, or both if the occupation requires the

patient to repeatedly strain his or her muscles. The intent of the device is not to restore full

function as compared with normal, healthy bone, and as such the patient should not hold high

expectations for post-operative functionality. ● Patient mental stability should be considered because of the chance that the patient will not

follow all recommended limitations and/or precautions, which can lead to failure of the device or

other complications. Whether or not the patient’s body will be sensitive to the implant as a foreign body

II. Device Description













material or biologics may be applied by the physician.

Osteova, Inc.


Traditional 510(k)

Confidential

III. Indications for Use










IV. Contraindications

● Infection ● Physiologically or psychologically inadequate patient ● Deficient skin, bone, or neurovascular status ● Severely damaged tendons ● Possibility for a more conservative treatment ● Children or adolescent patients, i.e. patients who are still growing Patients who normally have a high level of activity

V. Cautions

Federal law (USA) restricts this device to sale by or on the order of a physician.

VI. Precautions

● To mitigate potential complications or adverse reactions of the implanted device, follow the

instructions for use provided in product literature.

● It is the responsibility of the surgeon to evaluate the medical status, mental and physical, of each

patient and to be knowledgeable about implant surgery and any potential complications.

Understand that additional surgeries may be necessary to correct or replace the implant.

● Do NOT use the WedgeX™ Bone Wedge if excessive loading cannot be prevented.

● The intent of this implant surgery is to correct deformities in foot structure and reduce pain in

patients with such deformities. This is established by fusion of the bone to the implant. Excessive

forces can lead to delayed or failed bone fusion. Excessive forces may be a result of poor support,

joint instability, incorrect sizing, and overactivity.

● Proper use of the ancillary fixation during surgery is essential to the success of the implant.

● Following instructions for use provided by Osteova, Inc., proper implant sizing, stabilization of

deformities, and avoiding flawed implant surfaces will minimize the potential for post-operative

complications.

● It is imperative that the surgeon obtains informed consent for use of the device and adequately

explains all potential complications and adverse events with the patient, prior to surgery.

Osteova, Inc.


Traditional 510(k)

Confidential

● Clinical results of the device depend on the technique of the surgeon, pre- and post-operative

care, the chosen implant, patient evaluation, and daily activity.

● Inspect the device prior to use for any damages or defects.

● If it is necessary to remove an implant, inspect the device immediately after removal from the

patient for any damages.

● If the device is damaged or defective, retain it to assist with the analysis to be conducted by

Osteova, Inc.

● If necessary, discuss with the patient the potential risks of not retrieving a fragmented device.

This includes but is not limited to: location of the fragment, size of the fragment, events which

can cause subsequent injury, and procedures such as an MRI that should be avoided when

metallic fragments are of concern.

● Concern of Magnetic Resonance Environments

o The devices described in this package insert have not been evaluated for safety and

compatibility in a Magnetic Resonance (MR) environment. The devices described in this

package have not been tested for heating or migration when exposed to a MR environment.

VII. Adverse Events

As with any surgical procedure, there is a risk for adverse events associated with the surgery performed.

In regard to the WedgeX™ Bone Wedge, some potential adverse events associated with use of this device

include but are not limited to:

● Fracture of the implant ● Infection of the implant site ● Inflammation at the implant site ● Dislocation of the implant, requiring additional surgery to correct it ● Bone resorption/over-proliferation ● Allergic reaction(s) to the implant ● Embolism ● Migration of particulate debris due to normal wear, resulting in an immune response ● Unexpected immune response to the foreign body (the implant)

VIII. Packaging, Sterilization, and Storage

The WedgeX™ Bone Wedge is provided sterilized by ethylene oxide. Individual devices are packaged in

a Tyvek® pouch with a high-barrier foil backing. Multiple pouches come packaged in a dispenser box to

allow for easy retrieval when needed. WedgeX™ has a shelf life expiration date of 5 years and is labeled

accordingly on the pouch printing and the outer carton label. The device may be used up until the last day

of the month that is shown on the labeling. It is recommended to inspect the pouch integrity prior to opening. If a pouch has any cuts or rips that

might compromise sterility, or if there are any voids in any of the seals on the pouch, contact the

manufacturer for further instructions. Only use a device if the package integrity has not been

compromised. The pouches should be opened using proper aseptic operating room (OR) technique and

only after determining the proper size needed.

Osteova, Inc.


Traditional 510(k)

Confidential

The WedgeX™ Bone Wedge is for single use only and should never be re-used. It should never be re-

sterilized after being in contact with bodily tissues or fluids. The WedgeX™ Bone Wedge should be stored in a cool, dry location (41° - 77°F [5°-25°C]). Products

should be protected from sunlight and be located in a clean environment.

IX. Surgical Techniques

Proper aseptic OR technique should be used when opening the product pouch.

Specific sizing procedure as outlined in the instructions for use of the WedgeX™ Bone Wedge

must be followed.

X. Patient Population

The safety and effectiveness of the WedgeX™ Bone Wedge have not been established for the following

patient populations:

Patients who are pregnant or may become pregnant

Children and adolescent patients, i.e. patients who are still growing

XI. Life of Device

The WedgeX™ Bone Wedge is intended to be a permanent implanted device because the device

promotes bone growth around and throughout its porous structure. The device should be surgically

removed if the patients’ condition is not improved due to improper sizing, if the device is causing

inflammation or other adverse events to the patient, or if the device sustains damage after implantation

such as fracture. Contact the manufacturer with any questions regarding the removal of the device.

XII. Symbols Used on Packaging

This symbol indicates that the device should not be used more than once.

This symbol indicates that the device is sterilized by ethylene oxide.

This symbol indicates that the instruction manual should be referenced.

This symbol indicates to keep the product out of direct sunlight.

This symbol indicates the temperature range in which the device should be stored.

This symbol indicates that the product should not be used if the package is damaged.

This symbol indicates that the device is for prescription use only.

This symbol indicates to take caution and consult accompanying documents.

Osteova, Inc.


Traditional 510(k)

Confidential

This symbol represents the manufacturer’s address.

This symbol represents the List or Reference number of the device.

This symbol represents the Lot Number of the device

This symbol represents the Expiration Date, with respect to the device’s sterilization.

This symbol represents that the device can be marketed in certain European countries.

This symbol indicates the Authorized European Representative.

This symbol indicates to prevent the package from getting wet.

This symbol indicates that the contents of the package are fragile and to handle with care.

XIII. Contact Information

Osteova, Inc.

123 Sample Street

Los Angeles,

CA 90089

1-800-OSTEOVA

www.osteovainc.com/products/complaints.htm

http://www.osteovainc.com/products/complaints.htm

Osteova, Inc.


Traditional 510(k)

Confidential

Section 14 – Sterilization and Shelf Life

14.1 Ethylene Oxide (EO) Sterilization

The WedgeX™ Bone Wedge is provided sterile by ethylene oxide gas. The validation of this process is in

accordance with ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests

of sterility performed in the definition, validation and maintenance of a sterilization process, and EN 556:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1:

Requirements for terminally sterilized medical devices. The device is sterilized in three full-cycles to assure sterility of the product. Validation for this level of

sterilization was completed in two stages: 1) three half-cycles were run to confirm a Sterility Assurance

Level of at minimum 10-6; and 2) three full-cycles were run in order to provide assurance of product and

package integrity and determine that there are acceptable EO residual levels. The validation procedure

was completed in accordance with ISO11135-1: Sterilization of health care products - Ethylene oxide -

Part 1: Requirements for development, validation and routine control of a sterilization process for

medical devices. Determination of EO residual level after full-sterilization of the device was completed as

outlined in ISO 10933-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization

residuals. Bioburden testing of the device was also conducted to provide assurance that the acceptable limits of

biological contaminants are upheld. Validation protocols and reports for the sterilization process and bioburden testing, although not included

in this premarket notification, will be made available upon request.

14.2 Shelf Life

The WedgeX™ Bone Wedge has a maximum shelf life of 5 years from the date of sterilization. The

device may be used up until the last day of the month that is shown on the labeling. In compliance with

the standards of ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for

Medical Devices, accelerated aging studies for three years and five years were performed to determine

product integrity over its lifespan, with acceptable results. A real-time aging study is currently in process

to verify the results found in the accelerated aging studies. The reports for the stability tests are not

provided in this submission but will be made available upon request.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 15 – Biocompatibility

15.1 General Description

WedgeX™ Bone Wedge is a permanent bone implant and therefore directly contacts the patient.

Biocompatibility of the patient-contacting material is evaluated. The biocompatibility tests have

been performed in compliance with the biocompatibility matrix from United States Food and

Drug Administration Blue Book Memorandum G95-1, International Standards

Organization 10993-1 and 10993-12. The implanted device directly and permanently contacts tissue/bone, hence the following

evaluation tests to verify any toxic effects the device might cause on cells upon implant. The following table summarizes the tests performed, methods employed, and results obtained.

Table 10: Biocompatibility Testing

Test Method Test

Sample

Animal Standard Result

Cytotoxicity MEM Test Leachate Cellular ISO-10993-

:2009

Pass

Sensitization Maximization Leachate Guinea Pig ISO-10993-

10:2013

Pass

Irritation/Intracutaneous

Reactivity

Rabbit

Intracutaneous

Reactivity Test

Leachate

Rabbit

ISO-10993-

10:2013

Pass

Acute Systemic

Toxicity

Mouse Systemic

Injection


11:2009

Pass

Sub-chronic Toxicity Mouse Systemic

Injection


11:2009

Pass

Genotoxicity Ames Reverse

Mutation

Leachate S. typhimurium ISO-10993-

3:2009

Pass

Implantation Implantation Test Leachate Rabbit ISO-10993-

6:2009

Pass

Osteova, Inc.


Traditional 510(k)

Confidential

15.2 Test Details

The tests were performed according to ISO 10993 standards. The extract was prepared at X° C for Y

hours from ‘#’ number of rings in sesame oil.

I. Cytotoxicity

This test was performed using the MEM elution method to evaluate any toxic effects of metal bone

implant on growth of body cells. The extracts were filtered and placed in contact with a monolayer of L-

929 cells (mouse fibroblasts). The cells were incubated at 37 ± 2 ºC in 5 ± 1% CO2 for 72 ± 3 hours.

The cells were then scored for cytopathic effect. There was no sign of any cell damage, and thus we

consider our implant to be non-cytotoxic for body cells. A copy of the test report is not included in the

document but can be provided upon request.

II. Sensitization

Sensitization tests estimate the potential for contact sensitization of devices through the testing of

appropriate materials or extracts. Guinea pigs were exposed to the extract at 37°C for 72 hours, twice

within a 2-week period (Inductions I and II). The animals were re-exposed (challenged) 10-14 days after

Induction II by placing fresh extract in contact with previously unexposed skin. Over a 72-hour period,

the animals were observed for signs of a delayed allergic response when compared to a control group. If

the test results were equivocal, a re-challenge could be conducted within 7-10 days of the initial

challenge. Twelve animals were used, 6 irritant controls and 6 negative controls. Extract options

included normal saline and cottonseed oil. The turnaround time was 54 days (GLP). The test results

indicate the material is non-sensitizing. A copy of the test report is not included in the document but can

be provided upon request.

III. Skin Irritation

An extract of the device or biomaterial was prepared in up to 4 standard USP extraction solutions and

injected intracutaneously into rabbits to assess the irritancy of extractable compounds that might exist in

the biomaterial. The animals were observed for dermal reactions over a 72-hour period. The animals

exposed to the test article extract did not show significant signs of irritation above those observed in the

concurrent test control groups. The results indicated that the material is a non-irritant and does not

induce any kind of subcutaneous reaction. Extract options included normal saline, 5% ethanol in saline,

cottonseed oil, and polyethylene glycol. The turnaround time was 29 days (GLP). A copy of the results

is not included in the document but can be provided upon request.

Osteova, Inc.


Traditional 510(k)

Confidential

IV. Acute Systemic Toxicity and Sub-acute/Sub-chronic Toxicity

Multiple extracts of a device were prepared with standard polar and/or non-polar vehicles and injected

into 6 male and 6 female mice over the test time period. Two similar control groups were also injected

with the control vehicle. The extract conditions were administered at 37°C for 72 hours. The animals

were observed during the test time period for signs of toxicity and were subjected to a gross observation

at study termination. The animals were tested for their weight, survival, clinical observations, and gross

necropsy. Other parameters evaluated include clinical chemistry and hematology. Extract options

included normal saline and cottonseed oil. A copy of the test report is not included in the document but

can be provided upon request.

V. Genotoxicity

Genotoxicology tests evaluate the ability of a material to cause mutation or gross chromosomal damage.

Any materials intended for implantation or long term exposure should be evaluated for mutagenic

properties. The ISO Bacterial Reverse Mutation test was performed according to ISO 10993-3 using

OECD test method 471. Tester strains of bacteria (5 S. typhimurium or 4 S. typhimurium and 1 E. coli,

or 5 S. typhimurium and 1 E. coli) were exposed to the extracts of the test material in the presence and

absence of an exogenous metabolic activation system. One dose level of the test article per extract and

both positive and negative controls were used. The turnaround time was 28 days (GLP). A copy of the

test report is not included in the document but can be provided upon request.

VI. Implantation

The purpose of this study is to evaluate the potential for local effects of a test article, in direct contact

with skeletal muscle for an extended duration. Biomaterial was implanted intramuscularly into rabbits to

assess the reaction of the surrounding tissue. The implants remained in the muscle for the sponsor-

designated time period. Scoring of the sample and control reactions were the gross observations.

Histopathologic evaluation and photomicrographs (gross and histologic) will also be provided at the

request of the sponsor. The final analysis of the local effect of the test article is based on the clinical,

gross, and histopathology data. Microscopic evaluation will include such things as cell type, cell

distribution, and fibroplasia calcification. The turnaround time was 49 days. A copy of the test report is

not included in the document but can be provided upon request.

VII. Carcinogenicity

Carcinogenicity testing was not performed because the Genotoxicity test results were acceptable.

15.3 Conclusion

Metal bone implants are typically constructed of materials with known biocompatibility and history of

use in other devices. These materials have undergone biocompatibility tests in accordance with the FDA

biocompatibility guidance on ISO 10993-1, “Biological Evaluation of Medical Devices Part 1:

Evaluation and Testing." The above mentioned results show our device to be biocompatible for use in

human body and are as safe as the predicate device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 16 – Software

There is no software associated with this device. Therefore, software validation is not required for this

device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 17 – Electromagnetic Compatibility and Electrical Safety

There is no electric component associated with the WedgeX™ Bone Wedge.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 18 – Performance Testing: Bench

The table below summarizes the performance bench tests that were performed with this device.

Table 11: Bench Testing

Test Test Method Result Status

Conformational Structure

Analysis

FEM

(Finite Element Method

Testing)

TBD Pass

Static, Torsion and Fatigue

Testing

ASTM F1717* As per manufacturing

specifications

Pass

Flexural Fatigue Testing

Metallic Bone Plates

ASTM F382-99 As per manufacturing

specifications

Pass

Axial and Torsion Testing of

Bone Screws

ASTM F543 As per manufacturing

specifications

Pass

Characterization and Fatigue

of Spinal Intervertebral Body

Fusion Devices

ASTM F2077 – 11*

As per manufacturing

specifications

Pass

*Although ASTM F2077-11 and ASTM F1717 are written for spinal implants, the same basic methods

outlined in these standards may be applied for testing of other bone implants such as the WedgeX™ Bone

Wedge.

I. Characterization and Fatigue of Spinal Intervertebral Body Fusion Devices, ASTM F2077-11

This standard specifies a number of different static and dynamic tests to provide a mechanical comparison

between different fusion devices. The tests include:

● Axial-Compression ● Compression-Shear ● Torsion Testing

Figure 8: Static and Fatigue Testing Instrument. This axial-torsion

apparatus, the ElectroPuls™ E10000 Linear-Torsion All-Electric Dynamic

Test Instrument, allowed static and fatigue testing on the WedgeX™ Bone

Wedge. This system was combined with a temperature controlled bath,

which provided a stable environment for simulation of in vivo conditions.

With the use of specialized test fixtures, the combined axial-torsional

actuator in the crosshead allowed for conducting characterization in axial

compression, compression-shear, or compression-torsion tests modes. The

testing system allowed for mounting of the Biaxial Dynacell™ load cell on

the end of the moving axial-torsional actuator and automatically

compensated for errors caused by inertial loading.

http://www.instron.us/wa/product/ElectroPuls-All-Electric-Dynamic-Test-Systems.aspx

http://www.instron.us/wa/product/ElectroPuls-All-Electric-Dynamic-Test-Systems.aspx

Osteova, Inc.


Traditional 510(k)

Confidential

II. Axial and Torsion Testing of Bone Screws, ASTM F543

ASTM F543-07 Test A1: “Test Method for Determining the Torsional Properties of Metallic Bone

Screws” requires the screw to be sufficiently clamped and a rotational velocity between 1 and 5 rpm to be

applied until specimen failure and to measure the torque profile and the rotational angle.

ASTM F534-07 Test A2: “Test Method for Driving Torque of Medical Bone Screws” measures the

torque required to insert and remove the screw with a constant rotational velocity between 1 and 5 rpm,

while maintaining an axial load of no more than 10 N in compression.

ASTM F543-07 Test A3: “Test Method for Determining the Axial Pull-out Strength of Medical Bone

Screws” measures the force required to axially remove the screw that has been fully inserted in the test

block using the method from Test A2. The pull-out fixture then applies a tensile load at a constant rate of

5 mm/min until the failure of the bone screw or removal from the test block.

ASTM F543-07 Test A4:“Test Method for Determining the Self-Tapping Performance of Self-Tapping

Medical Bone Screws” specifies the procedure to evaluate the axial loading required to engage a self-

tapping bone screw into a standard laboratory material. Although considered a simple clinical procedure,

reproduction in vitro results in a relatively complex motion due to the interaction between the rotation and

linear axes of a test machine. The test requires a continuous rotational velocity of up to 30 rpm, while the

axial load is incremented during the insertion at a rate of 2 N/s. The objective of the test is to record the

torque profile as the bone screw is inserted into the material and then removed.

The ElectroPuls™ E10000 Linear-Torsion machine is an all-electric dynamic test system that provides a

unique linear and torsion actuator system that is capable of synchronized linear and multi-rotation testing

and is the ideal platform for performing the full range of tests prescribed by the standard. The combined

actuator package is mounted in the upper crosshead of the machine, leaving the base clear for mounting of

the biaxial Dynacell™ load cell and the fixtures to hold the material and bone screw. We control the test

system by using WaveMatrix™ Dynamic Test Software. This provides the ability to easily set up the

multi-axial tests as a series of steps and displays the required information as a test proceeds. Special

fixtures are used to clamp the material to the biaxial load cell and a drill chuck used for the drive bits.

Osteova, Inc.


Traditional 510(k)

Confidential

III. Flexural Fatigue Testing Metallic Bone Plates, ASTM F382-99

Testing was based on standard ASTM F382 - Standard Specification and Test Method for Metallic Bone

Plates. The test fixture accurately replicated bending movement during a single cycle test, as well as

fatigue evaluation of the plate material and design. The four-point bending fixture is comprised of two

loading rollers near the center of the loading fixture and two support rollers at the ends of the fixture. The

rollers are available in various sizes to cater for different size bone plates.

Figure 9: Flexural Fatigue Testing Instrument. This apparatus was

designed for use with our 8870 Series Servohydraulic Test Systems,

which is ideally suited to both static and dynamic tests. The setup can also

incorporate a deflectometry system (both in and out of an environmental

bath) to measure central deflection of the fixation device.

IV. Spinal Constructs – Static, Torsion, and Fatigue Testing, ASTM F1717

During normal patient activity, spinal constructs can be subjected to high in vivo loading, which may

result in catastrophic failure. Simple static testing must be performed to evaluate the compressive, tensile

and torsional loading required to fracture the spinal construct. Service life testing of spinal constructs is critical, as fatigue failure is more common than catastrophic

failure. Loading is typically applied with a constant-amplitude, load-controlled sinusoidal waveform,

running in excess of five million cycles. ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, specifies

methods for both the static and fatigue testing of spinal implant assemblies. For the majority of spinal construct testing, ultra-high molecular weight polyethylene (UHMWPE) blocks

were used, rather than vertebrae, to eliminate the variances that bone properties and geometry may

introduce. Static software test packages, such as Bluehill®, were used to record load-displacement curves

and to perform calculations required by the ASTM standard. A fatigue tester with a high-speed closed-loop multi-channel controller called MTESTQuattro® Dynamic

was used. MTESTQuattro® produced sine, square, and triangular waveforms based on force,

displacement, torque, or angle amplitude control. Users can manually adjust control gains and end point

values on the fly or activate amplitude control, so that the controller automatically adjusts the end point

values to ensure waveform amplitudes stay within tolerance. Biaxial systems employ two axes of control

that can be programmed to operate independently or in unison.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 19 – Performance Testing: Animal

Performance testing using animals was not conducted for this device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 20 – Performance Testing: Clinical

Clinical performance testing was not required or performed for this device.

Osteova, Inc.


Traditional 510(k)

Confidential

Section 21 – List of Referenced Standards and Guidance Documents 1. ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within

a risk management process

2. FDA G95-1 – 510(k) Memorandum: Table 1 Initial Evaluation Tests for Consideration

3. ISO-10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

4. ISO-10993-10:2013 - Biological evaluation of medical devices - Part 10: Tests for irritation and

skin sensitization

5. ISO-10993-11:2009 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

6. ISO-10993-3:2009 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity,

carcinogenicity and reproductive toxicity

7. ISO-10993-6:2009 - Biological evaluation of medical devices - Part 6: Tests for local effects after

implantation

8. ASTM F2077 – 11 - Test Methods for Intervertebral Body Fusion Devices

9. ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws

10. ASTM F382-99 - Standard Specification and Test Method for Metallic Bone Plates

11. ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

12. ASTM F1886/F1886M – Standard Test Method for Determining Integrity of Seals for Flexible

Packaging by Visual Inspection

13. AAMI/ANSI/ISO 11135 Standards: Sterilization of health care products - Ethylene oxide

14. ISO 11607: Packaging for terminally sterilized medical devices

15. ASTM D4728: Test Method for Random Vibration Testing of Shipping Containers

16. ASTM D5276: Test Method for Drop Test of Loaded Containers by Free Fall

17. ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility

performed in the definition, validation and maintenance of a sterilization process

18. EN 556: Sterilization of medical devices - Requirements for medical devices to be designated

"STERILE" - Part 1: Requirements for terminally sterilized medical devices

19. ISO11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for

development, validation and routine control of a sterilization process for medical devices.

20. ISO 10933-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Osteova, Inc.


Traditional 510(k)

Confidential

21. ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials

22. ASTM F2475 – 05: Standard Guide for Biocompatibility Evaluation of Medical Device Packaging

Materials

23. ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

24. ISO 10993-12: 2012 - Biological evaluation of medical devices - Part 12: Sample preparation and

reference materials