AnSong Medical's Zirconia Ceramic Femoral Head Receives NMPA Approval for Market Launch

Recently, the National Medical Products Administration approved the innovative product registration application for "Zirconia Ceramic Femoral Head" by Arthrone Co., Ltd.

This product is a hip joint prosthesis component made of zirconia ceramic material. It is used in conjunction with other components from the same series by the same company and is suitable for hip joint replacement.

This product adopts high and low temperature cyclic sintering technology, which reduces the high temperature of sintering. This provides the driving force for grain boundary diffusion while avoiding performance issues caused by excessively high temperatures. Compared with metal femoral heads, the chemical inertness of zirconia ceramic femoral heads can effectively prevent the release of metal ions, reducing the occurrence of prosthesis loosening, while also offering better biocompatibility.

The drug supervision and administration department will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.

Source: National Medical Products Administration

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