Jiaste Medical Receives NMPA Approval for Innovative Cementless Knee Implant System

Recently, the National Medical Products Administration approved the innovative product registration application for the biologic knee joint prosthesis system by Just Medical (Tianjin) Co., Ltd.

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

The pharmaceuticals regulatory department will strengthen the post-market supervision of this product to protect patient safety in medical device use.