All-polymer knee implant poised to enter pre-clinical trials in China

Solvay Specialty Polymers (Brussels) has announced that China-based artificial joint manufacturer Okani Medical Technology has developed an all-polymer knee implant using Solvay’s Zeniva polyetheretherketone (PEEK). Okani’s novel ORGKnee implant offers a longer service life at a lower cost than traditional metal-based implant systems. Solvay will feature the device at the annual meeting of the American Academy of Orthopedic Surgeons this week in New Orleans. 

Polymer knee implant from Okani Medical Technology using Solvay’s Zeniva PEEK

Okani evaluated Zeniva PEEK’s suitability for the femoral and tibial tray components of its knee implant according to ISO 14243-1:2009, which simulates normal walking behavior over 10 years. The findings, which Okani will present at the Orthopaedic Research Society 2018 Annual Meeting from March 10 to 13 in New Orleans, indicate that its PEEK-based knee implant exhibited 50% less wear than a metal implant, as measured by material loss over 3 million cycles.

Okani selected Zeniva PEEK, in part, because of the material’s success in spinal implant applications, according to a press release from Solvay. Unlike implants made of cobalt chrome or titanium alloys, devices molded from Zeniva PEEK exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime because of significantly reduced wear of the total knee-joint prosthesis, said Solvay. 

“PEEK’s injection molding capability makes large-scale production of ORGKnee implants possible in a fraction of the time and cost it takes to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment,” said the chief technology officer at Okani. 

Okani’s ORGKnee implant enters pre-clinical trials this April before undergoing standard clinical trials by China’s Food and Drug Administration in September 2018. The company plans to commercially launch the implant in 2020.

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