Add Strength and Stability Without Adding Metal

1. In Vitro Data on File at OSSIO.

+

The Bio-Integrative OSSIOfiber® Trimmable Fixation Nail FamilyAll Natural Healing for Multiple Applications

Tapered ends* Facilitate easy insertion

Screw-like Stability1 with the Utility of a Trimmable Nail that Leaves Nothing Permanent Behind

Bio-IntegrationAbility to fully integrate into surrounding bone without adverse inflammation, leaving nothing permanent behind

Trimmable material Customize to desired length before or after insertion

BarbsSupports strength needed for bone fixation

Hexagonal shapeResists rotation

Comprised of a first-of-its-kind implant material, OSSIOfiber® Intelligent Bone Regeneration Technology

StrengthHigh performing matrix of reinforcing mineral fibers yield strength 1.5x stronger than cortical bone1

The OSSIOfiber® Trimmable Fixation Nail Family

1. In Vitro Data on File at OSSIO.* Only 2.4x50 and 4.0x50 solid-core are tapered on both ends

4.0x50mm 2.4x50mm 2.4x30mm (x2)

Solid-Core

Cannulated

3.0x50mm & 4.0x70mm

2. In Vitro Data on File at OSSIO3. In Vitro Flexural Strength Test in a Simulated Osteotomy Construct. Data on File at OSSIO. 4. In Vitro Initial Pull Out Strength of 2.4x50mm OSSIOfiber® Trimmable Fixation Nails. Data on File at OSSIO. 5. Pre-clinical animal studies (in-bone implantation of OSSIOfiber® and PLDLA control in rabbit femurs). Data on File at OSSIO.

Superior rotational resistance over cannulated headless metal

compression screws2

Outperforms cannulated metal compression screws in preventing

loosening which can result in screw back-out2

Headless Metal Cannulated

Compression Screws

Hexagonal OSSIOfiber®

Nails

Strong pull out strength4

250

200

150

100

50

0

New

tons

Initial stability and fixation strength comparable to cannulated

headless compression screws3

Can maintain compression2

Simulated osteotomy construct testedFor illustrative purposes only

Metal can cause unwanted pain and complications often leading to secondary hardware removal surgeries

Each metal implant can obstruct up to 24% of the fusion surface area with a permanent material2

Bio-integrative OSSIOfiber® enables full bone-to-bone fusion

OSSIOfiber® fully integrates into surrounding bone without adverse inflammation, leaving only nature remaining5

OSSIOfiber® Nails increase the bone attachment surface area by over 5X through gradual bone in-growth spanning the full length of the implant 2

Fixation Healing Healed

Performance that rivals metal compression screws

Maximize the Fusion Area with Intelligent Bone Regeneration

Ordering information

IndicationsThe OSSIOfiber® Trimmable Fixation Nails were designed for broad utility across foot/ankle and hand/wrist applications. These strong and biointegrative implants can be utilized as the primary fixation or adjunct fixation.

The following list indicates the common procedures for anticipate use with the OSSIOfiber® Trimmable Fixation System and is not intended to be all-encompassing.

Common Indications

Implant Size(s)

1st Metatarsal Osteotomy 2.4, 3.0

Akin Bunionectomy 2.4, 3.0

Metatarsal Shortening Osteotomy (Weil) 2.4, 3.0

Bunionette (Tailor’s Bunion) 2.4, 3.0

MPJ/MTP Fusion 2.4, 3.0

2nd – 4th Metatarsal Osteotomies 2.4, 3.0

DIP/PIP Joint Fusion (Hammertoe Correction) 2.4, 3.0

MIS Bunion 3.0, 4.0

Lapidus 3.0, 4.0

TMT Joint Fusion 4.0

Naviculor Cuneiform Fusion 4.0

Talonavicular Fusion 4.0

Medial Malleolar 4.0

Calcaneal Osteotomy 4.0

Subtalar Fusion 4.0

Triple Arthrodesis 4.0

Intramedullary Metacarpal Fracture Repair 3.0, 4.0

Distal Radius Fracture Repair 3.0, 4.0

Fore

foot

Hin

dfoo

t/A

nkle

M

idfo

otH

and

&

Wris

t

Sterile, disposable instrumentation Convenient and streamlined OR preparation

Description Product Code

OSSIOfiber® Trimmable Fixation Nail System, 2.4 x 30mm, Two Implants OF2012430S

OSSIOfiber® Trimmable Fixation Nail System, 2.4 x 50mm, One Implant OF2012450S

OSSIOfiber® Trimmable Fixation Nail System, 4.0 x 50mm, One Implant OF2014050S

OSSIOfiber® Trimmable Fixation Nail System, 4.0 x 50mm, Two Implants OF2044050S

OSSIOfiber® Cannulated Trimmable Fixation Nail System, 3.0 x 50mm, One Implant OF2053050S

OSSIOfiber® Cannulated Trimmable Fixation Nail System, 4.0 x 70mm, One Implant OF2054070S

DOC001184 Rev 4.0 07/2021 ® OSSIO and OSSIOfiber are registered trademarks of OSSIO Ltd. All rights reserved. OSSIO Inc. 300 Tradecenter Drive, Suite 3690, Woburn, MA 01801 For more on OSSIO and OSSIOfiber®, please visit ossio.io or call 833-781-7373 Not commercially sold outside the US

For Solid-Core instrumentation kit: two K-Wires, Cannulated Drill Bit, Depth Gauge, TampFor Cannulated instrumentation kit: two K-Wires, Cannulated Drill Bit, Depth Gauge/TampSystem configurations include an instrumentation kit in addition to the implant/s.

NOTE: Solid-Core sizes are 2.4 and 4.0 and cannulated are 3.0 and 4.0