TAMPERE, Finland, August 19 /PRNewswire/ -- Inion, one of the leading companies in the field of developing biodegradable medical implants, announces FDA 510(k) clearance of its Trinion(TM) Meniscus Screw for use in knee cartilage repair. This clearance allows Inion's Trinion(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) screws are used for the fixation of longitudinal vertical meniscus lesions, where the knee cartilage has torn. The benefits of the Trinion(TM) 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(TM) was awarded a CE-mark, the European equivalent of 510(k) clearance in July 2003. Trinion(TM) will be available in North America through Inion's sports medicine distributor, Lifeline Biotechnologies, which currently markets Inion's Hexalon(TM) product for anterior crucial ligament repair. Trinion(TM) 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.
Inion Ltd. is a Finnish company specialising in the development of biodegradable medical implants. Inion's core expertise and technology lies in the design and manufacture of innovative biodegradable polymer devices, such as plates, screws, pins and membranes. These implants are used to enhance the healing of skeletal injuries (bone and soft tissue), such as those caused by trauma or by reconstructive surgery. Inion uses expertise in polymer chemistry and surgical techniques to develop systems with strength and degradation profiles tailored for each surgical application.
Inion was founded in 1999 by an international team of experts in biodegradable materials and related clinical applications. The Company has production and R&D facilities at the corporate headquarters in Tampere, Finland, and a US office in Oklahoma City, OK. Inion has developed and launched products in four strategic business areas - craniomaxillofacial surgery, orthopaedic trauma, sports medicine and dental surgery - in 35 countries worldwide, and has a number of international distribution agreements in place, including Stryker Sales Corporation and Citagenix in North America and Aesculap in Central Europe.