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Zirconium Niobium Alloy Femoral Head Approved for Marketing

CCFDIE|Updated: 2023-06-16

     

Recently, the innovative product Zirconium Niobium Alloy Femoral Head of Suzhou MicroPort Orthopedics Medical Technology Co., Ltd. is approved by China NMPA.

The zirconium niobium alloy femoral head is used in conjunction with the components of hip joint prosthesis from the same series of this enterprise, applicable for total hip joint replacement. This product adopts zirconium niobium alloy that meets international standards (ASTM F2384), and forms a ceramic layer on the surface through gradient oxidation, which can reduce the wear rate of highly cross-linked polyethylene liner and reduce the revision rate of hip joint prostheses.

Compared with cobalt chromium alloy femoral heads commonly used in clinical practice, this product can reduce metal ion precipitation and joint surface wear; Compared with ceramic femoral heads, it can reduce the risks such as prosthesis fragmentation and joint noise. The marketing of this product will provide more options for clinical treatment.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.