Solvay recently announced that its Zeniva® PEEK polymer has helped China's pioneering artificial joint application, O'Connell Medical Technology Development Co., Ltd. (hereinafter referred to as O'Connell), to develop a mature all-polymer knee joint implant. Inclusion. Compared with traditional metal implants, O'Connell's newly developed ORGKnee® implants can achieve a longer lifespan at a lower cost. Solvay will debut at CHINAPLAS 2018 at its stand. Various sizes of ORGknee® implants.
O'Connell evaluated the suitability of Zeniva® PEEK for femoral condylar and tibial trays for knee implants according to ISO 14243-3 (which simulates normal walking behavior over 10 years). This assessment measures material wear after 3 million cycles. The results show that the ORGKnee® implant developed with Zeniva® PEEK has a 50% lower wear than metal implants.
O'Connell chose Zeniva® PEEK as an ORGKnee® implant material because, in part, the material has been successfully applied to spinal implants. Compared to cobalt-chromium or titanium alloy implants, Zeniva® PEEK and the human body The modulus of the bone is very close, reducing stress shielding. At the same time, the implant can also significantly reduce the overall wear of the knee prosthesis, allowing it to have a longer period of stability, thereby prolonging the life of the implant.
O'Connell's technical director Zhu Zhonglin said: 'The production of metal implants, including: manufacturing, processing and polishing, takes as long as three months, and the production methods may cause harm to workers and the environment. By comparison, Zeniva® PEEK has excellent injection molding capabilities and can therefore be used to mold ORGKnee® implants, enabling mass production with minimal time and cost.
Jeff Hrivnak, Medical Global Development Manager, Solvay Specialty Polymers Business Unit, said: “The O'Connell ORGKnee® Implant not only perfectly embodies the unique performance of Zeniva® PEEK, but also showcased Solvay's open innovation business model – through Medical device customers collaborate to help them promote innovation and optimize technology.
O'Connell's ORGKnee® implants enter preclinical trials in April this year, and will then undergo standard clinical trials of the State Food and Drug Administration (CFDA) in September 2018. O'Connell plans to receive ORGKnee approval in 2020 after receiving CFDA approval. TM solution commercialization.