Zirconia Ceramic Femoral Head Approved for Marketing
Recently, the innovative product "Zirconia Ceramic Femoral Head" of Beijing Arthrone Technology Co., Ltd. is approved for marketing by China NMPA.
This product is a component of a hip joint prosthesis, made from zirconia ceramic material, and is designed to be used in conjunction with other components from the same series of the same enterprise. It is indicated for hip joint replacement.
This product uses a high-low temperature cyclic sintering technique, which reduces the high-temperature sintering temperature, providing driving force for grain boundary diffusion while avoiding performance issues caused by excessively high temperatures. Compared to metal femoral heads, the chemical inertness of the zirconia ceramic femoral head effectively prevents the release of metal ions, reducing the risk of prosthesis loosening and offering better biocompatibility.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.