Inion OTPS TM. The Biodegradable Solution. lnion OTPS TM Plating Systems. Product description

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1 Inion OTPS TM 2 lnion OTPS TM Plating Systems The Biodegradable Solution

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3 Bio-advantage with Inion Technology 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 OTPS TM 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. Inion OTPS TM Biodegradable Ankle Plating System has shown its benefits in clinical follow-up and studies. Two independent studies have demonstrated that Inion OTPS TM Biodegradable Ankle Plating System provides similar ankle fracture healing results in comparison to metal plates 1. In a randomized, prospective, double-blinded multicenter study comparing the Inion OTPS TM Ankle Plate to a conventional Synthes titanium plating system, functional recovery was similar in both groups. This study included 40 patients with 12 months followup. 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 followup study of 50 ankle fracture patients treated with Inion OTPS TM Biodegradable Ankle Plating System 2. 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 OTPS TM implants have been tailored for safe biodegradation. Inion OTPS TM 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. Demonstrated Clinical Performance 1 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

4 Inion FreedomPlate TM Versatile Fracture Fixation Inion FreedomPlate TM 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 2 Indications Inion FreedomPlate TM ordering information 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 Art. No. Description Qty FRF x 65 mm concave plate 1 FRF x 100 mm concave plate 1 FRF x 23 mm screw 2 FRF x 40 mm screw 1 FRF x 18 mm screw 1 FRF x 40 mm screw 1

5 Inion OTPS TM Ankle Plating System Inion OTPS TM 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 OTPS TM Ankle System ordering information Art. No. Description Qty FRF hole plate, left 1 FRF hole plate, right 1 FRF x 23 mm screw 2 FRF x 40 mm screw 1 FRF x 18 mm screw 1 FRF x 40 mm screw 1 3 FRF x 45 mm partially threaded screw 1 FRF x 50 mm partially threaded screw 1 FRF x 55 mm partially threaded screw 1 FRF x 45 mm fully threaded screw 1 FRF x 50 mm fully threaded screw 1 FRF x 55 mm fully threaded screw 1 FRF x 90 mm cannulated cortex screw 1 (syndesmosis screw) Inion OTPS TM Ankle plates have not been cleared for sale in the USA.

6 Inion OTPS TM Mini System Inion OTPS TM Mini System includes screws and plates for small bone fractures and osteotomy fixation of the hand. Inion OTPS TM pins can be used together with Inion OTPS TM 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. 4 Inion OTPS TM Mini ordering information Art. No. Description Qty FRF x 20 mm screw 2 FRF x 14 mm screw 2 FRF x 23 mm screw 2 FRF x 23 mm screw 2 FRF x 40 mm screw 2 PIN x 50 mm pin 1 PIN x 50 mm pin 1

7 Inion OTPS TM Mesh System The Inion OTPS TM 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 OTPS TM Mesh ordering information Art. No. Description Qty MSH-1035 Mesh plate, 14 x 14 holes 1 FRF x 14 mm screw 2 FRF x 23 mm screw 2 FRF x 18 mm screw 1 FRF x 45 mm fully threaded screw 1 5

8 INION OY Lääkärinkatu 2 FI Tampere, FINLAND tel: fax: info@inion.com internet: INION INC 2800 Glades Circle Suite 138, Weston FL USA Toll-free tel: 866-INION-US tel: fax: version 2: 10/2011