Aug 20 2004
Inion, one of the leading companies in the field of developing biodegradable medical implants, announces FDA 510(k) clearance of its Trinion™ Meniscus Screw for use in knee cartilage repair. This clearance allows Inion’s Trinion™ screws to be marketed and sold in the US, complementing the previously offered HexalonTM biodegradable cruciate ligament repair screw, in the world’s largest market for sports medicine and orthopaedic products.
Inion’s leading position in biodegradable implants is based on its proprietary Optima™ family of biomaterials, made by blending rigid and elastic polymer components to create implants with the most appropriate strength, malleability and degradation profiles to meet their specific clinical requirements. The carefully tailored polymer mix allows the Trinion™ screw to degrade through normal metabolic pathways to carbon dioxide and water.
Commenting on the approval, Auvo Kaikkonen, CEO, said, “We are delighted to receive clearance from FDA for our Trinion™ product. We believe that biodegradable implants will have a significant role to play in the future of orthopaedics. They have obvious benefits in many areas, not only for patients but also for surgeons and the health industry in general. We are confident that our growing range of products based on our Optima™ family of biomaterials will allow us to compete in the biodegradable implant market globally, assisting Inion in its pursuit of its ambitious growth targets."
Trinion™ screws are used for the fixation of longitudinal vertical meniscus lesions, where the knee cartilage has torn. The benefits of the Trinion™ screw include a dual thread screw for optimal fixation with a headless design to allow complete insertion into the meniscus to avoid chondral lesion development. To aid surgeons, the screws are coloured to allow improved visibility in arthroscopic procedures and are cannulated for increased ease of insertion.
510(k) clearance from the FDA is awarded to medical device manufacturers prior to commercial distribution in the US. Trinion™ was awarded a CE-mark, the European equivalent of 510(k) clearance in July 2003. Trinion™ will be available in North America through Inion’s sports medicine distributor, Lifeline Biotechnologies, which currently markets Inion’s Hexalon™ product for anterior crucial ligament repair. Trinion™ is currently available through distribution agreements and company sales forces in Germany, Austria, Finland, Italy, Spain, Greece, Switzerland, Czech Republic., Australia, South Africa, UAE, Argentina, Chile and South Korea.
For more information on biomaterials, click here.