Jasite Medical's Biotype Knee Prosthesis System Gains NMPA Approval as Innovative Orthopedic Device

This product is composed of femoral condyles, tibial trays, tibial tray inserts, positioning posts, and compression rods. Among these components, the femoral condyle parts are made from cast cobalt-chromium-molybdenum alloy material that complies with the YY 0117.3 standard, with a plasma-sprayed pure titanium coating on the inner surface, where the coating material meets the requirements of the YY/T 0988.2 standard; the tibial tray parts are manufactured using Ti6Al4V ELI powder through an electron beam melting additive manufacturing process, with chemical composition and mechanical properties conforming to the YY 0117.2 standard; the tibial tray insert parts are made from highly cross-linked ultra-high molecular weight polyethylene containing vitamin E (brand name Chirulen® 1020EX), which complies with the YY/T 0811 standard; the positioning posts and compression rod parts are made from TC4 titanium alloy material in accordance with the GB/T 13810 standard.This product is used as a non-cemented prosthesis and is suitable for primary total knee arthroplasty.