inion otps product description tm€¦ · they degrade in the body and are metabolised into carbon...

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Inion OTPS TM The Biodegradable Solution lnion OTPS TM Plating Systems

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Page 1: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

Product description

2

Inion OTPS TM

The

Bio

degr

adab

le S

olut

ion

lnio

n O

TPSTM

Pla

ting

Syst

ems

Page 2: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product
Page 3: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

Bio-advantage with Inion® Technology

1

Core Technology

Inion’s core technology is based on the biological and

mechanical principles of natural bone healing. The

company’s expertise is based on several decades of

experience with biodegradable polymers and exemplified

by the proprietary Biodegradable Inion® Polymers.

Biodegradable Inion® Polymers are made by blending

rigid and elastic polymer components to create implants

with optimal strength, malleability and degradation profile

to meet their specific clinical requirements.

Biodegradable Inion® Polymers used for the Inion OTPSTM

Plating Systems are made of L-lactide, D,L-lactide and

trimethylene carbonate (TMC).

A key benefit of Biodegradable Inion® polymers is that

they degrade in the body and are metabolised into carbon

dioxide and water. The rate of degradation is predictable

and tailored to provide initial stability and then, as the

implant loses its strength, to progressively transfer the

load to bone to stimulate regeneration.

Demonstrated Clinical Performance

Inion OTPSTM Biodegradable Ankle Plating System has

shown its benefits in clinical follow-up and studies.

Two independent studies have demonstrated that Inion

OTPSTM Biodegradable Ankle Plating System provides

similar ankle fracture healing results in comparison to

metal plates1.

In a randomized, prospective, double-blinded multicenter

study comparing the Inion OTPSTM Ankle Plate to a

conventional Synthes titanium plating system, functional

recovery was similar in both groups.

This study included 40 patients with 12 months follow-

up. The operated ankle was immobilised with a plaster

cast for 6 weeks. Partial weight bearing was allowed

after 3 weeks of immobilisation. Full weight bearing was

allowed after cast removal.

These results are supported by retrospective follow-

up study of 50 ankle fracture patients treated with Inion

OTPSTM Biodegradable Ankle Plating System2. According

to this study the biodegradable plating system provides

fracture healing and functional results comparable to

those previously reported with metal fixation.

Gradual Material Degradation Profile Ensures Safe Resorption

Biodegradable Inion® Polymers used in Inion OTPSTM

implants have been tailored for safe biodegradation.

Inion OTPSTM implants retain most of their strength up to

9-12 weeks and gradually lose their strength thereafter.

Biodegradation takes place within two to four years.

1. Andreassen G , Kainonen T, Brink O, Kurkinen M:

Healing of ankle fractures: Comparison of biodegradable

and metal plate and screws. AAOS 2008 Annual

Meeting Podium Presentation No.504. Manuscript to be

submitted for publication.

2. Kukk A, Nurmi J. Retrospective follow-up of 50 ankle

fracture patients treated with a biodegradable plating

system. Foot and Ankle Surgery, Volume 15, Issue 4,

December 2009, Pages 192-197.

Page 4: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

2

Inion FreedomPlateTM – Versatile Fracture Fixation

Product description

Inion FreedomPlateTM is a versatile fracture fixation

system. The system includes a fully customisable plate

which contours to all anatomies, and fixation screws

which can be implanted polyaxially to provide the best

possible fixation.

Benefits

Customised plate for every patient

Can be tailored along the operation to meet the

challenging anatomies

Low inventory quantities of plates and screws

Low profile – low risk of tissue irritation

Variable screw angulations

Screws interlock with the plate – low risk of screw

back-out

Flexible placement of the screws

Transparent and radiolucent

Indications

Maintenance of alignment and fixation of

- bone fractures

- osteotomies

- arthrodeses

of long bones, flat bones, short bones, irregular bones,

appedicular skeleton and thorax, in the presence of

appropriate additional immobilisation or fixation

Maintenance of relative position of weak bony tissue in

trauma and reconstructive procedures, i.e.:

- bone grafts

- bone graft subsitutes

- bone fragments in comminuted fractures

Inion FreedomPlateTM ordering information

Art. No. Description Qty

FRF-1065 20 x 65 mm concave plate 1

FRF-1066 20 x 100 mm concave plate 1

FRF-1262 2.8 x 23 mm screw 2

FRF-1217 2.8 x 40 mm screw 1

FRF-1270 3.1 x 18 mm screw 1

FRF-1271 3.1 x 40 mm screw 1

Page 5: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

3

Inion OTPSTM Ankle Plating System

Product description

Inion OTPSTM Ankle Plating System is the first

biodegradable complete ankle fracture system available

in the market. The system includes plates and screws

for fixation of lateral malleolar fractures, a syndesmotic

screw and cancellous bone screws for fixation of

malleolar fractures where plating is not required.

Benefits

Contours perfectly to patient anatomy

Screws can be trimmed to length – lower

inventory quantities

Low profile – low risk of tissue irritation

Variable screw angulations

Flexible placement of syndesmotic screw

Transparent and radiolucent

Indications

General indications: Maintenance of reduction and

fixation of cancellous bone fractures, osteotomies or

arthrodeses of the upper extremity, ankle and foot in

the presence of appropriate plaster cast immobilisation

Specific indications:

- Fractures and osteotomies of the malleoli

- Ankle fractures

Inion OTPSTM Ankle plates have not been cleared for sale in the USA.

Inion OTPSTM Ankle System ordering information

Art. No. Description QtyFRF-1056 8 hole plate, left 1FRF-1057 8 hole plate, right 1

FRF-1262 2.8 x 23 mm screw 2FRF-1217 2.8 x 40 mm screw 1FRF-1270 3.1 x 18 mm screw 1FRF-1271 3.1 x 40 mm screw 1

FRF-1272 4.5 x 45 mm partially threaded screw 1FRF-1273 4.5 x 50 mm partially threaded screw 1FRF-1274 4.5 x 55 mm partially threaded screw 1FRF-1245 4.5 x 45 mm fully threaded screw 1FRF-1277 4.5 x 50 mm fully threaded screw 1FRF-1278 4.5 x 55 mm fully threaded screw 1 FRF-1275 4.5 x 90 mm cannulated cortex screw 1 (syndesmosis screw)

Page 6: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

4

Inion OTPSTM Mini System

Product description

Inion OTPSTM Mini System includes screws and plates

for small bone fractures and osteotomy fixation of the

hand. Inion OTPSTM pins can be used together with Inion

OTPSTM Mini system.

Benefits

Transparent and radiolucent

Screws can be trimmed to length – lower

inventory quantities

Strong enough for long enough – then biodegrades

Indications

Intended for fixation of non-comminuted diaphyseal

fractures of the metacarpal, proximal phalangeal,

middle phalangeal and osteotomies in the presence of

appropriate immobilisation.

Inion OTPSTM Mini ordering information

Art. No. Description Qty

FRF-1289 2.0 x 20 mm screw 2

FRF-1250 2.5 x 14 mm screw 2

FRF-1253 2.5 x 23 mm screw 2

FRF-1262 2.8 x 23 mm screw 2

FRF-1217 2.8 x 40 mm screw 2

PIN-1550 1.5 x 50 mm pin 1

PIN-2050 2.0 x 50 mm pin 1

Page 7: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

5

Inion OTPSTM Mesh System

Product description

The Inion OTPSTM Biodegradable Mesh Fixation System

is designed for graft containment and to sustain the

relative position of bone fragments.

Benefits

Contours perfectly to patient anatomy

Low profile – low risk of tissue irritation

Variable screw angulations

Flexible placement of the screws

Transparent and radiolucent

Indications

Intended to sustain the relative position of weak bony

tissue, e.g., bone grafts, bone graft substitutes, or bone

fragments from comminuted fractures.

Indicated for cement restriction in total joint arthroplasty

procedures.

Only when used in conjunction with traditional rigid

fixation, these implants are intended to sustain the

relative position of weak bony tissue in trauma and

reconstructive orthopaedic procedures involving the

following:

- Long bones

- Flat bones

- Short bones

- Irregular bones

- Appendicular skeleton

- Thorax

When used alone (without traditional rigid fixation), these

implants are intended to maintain the relative position of

bone grafts or bone graft substitutes in reconstructive

orthopaedic procedures involving:

- Tumor resections where bone strength has not been

compromised

- Iliac crest harvest sites

Inion OTPSTM Mesh ordering information

Art. No. Description Qty

MSH-1035 Mesh plate, 14 x 14 holes 1

FRF-1250 2.5 x 14 mm screw 2

FRF-1262 2.8 x 23 mm screw 2

FRF-1270 3.1 x 18 mm screw 1

FRF-1245 4.5 x 45 mm fully threaded screw 1

Page 8: Inion OTPS Product description TM€¦ · they degrade in the body and are metabolised into carbon dioxide and water. ... Inion FreedomPlateTM – Versatile Fracture Fixation Product

INION OYLääkärinkatu 2FI-33520 Tampere, FINLANDtel: +358-10-830 6600fax: +358-10-830 6601email: [email protected]: www.inion.com

INION INC2800 Glades CircleSuite 138, WestonFL 33327USAToll-free tel: 866-INION-UStel: 954-659-9224·fax: 954-659-7997

30000311version 2: 10/2011