MicroPort® Orthopedics Zirconium-Niobium Alloy Femoral Head Gains Access to China’s Special Approval Procedure for Innovative Medical Devices

Suzhou, China, 11 November 2021 — A zirconium-niobium alloy femoral head, designed and developed by Suzhou Minimally Invasive Orthopedics (Group) Co., Ltd. (MicroPort® Orthopedics), has been given access by the National Medical Products Administration (NMPA) of China to enter the ‘Green Path’, the special approval procedure for innovative medical devices. This marks a total of 25 products by MicroPort® or affiliated companies to have entered the through this approval pathway.

Thanks to its innovative material, the 'Green Path'-ready zirconium-niobium alloy femoral head offers the merits of both metal and ceramic femoral heads. It consists of a zirconium-oxide ceramic layer on the surface and a zirconium-niobium alloy on the inside, with an oxygen-enriched layer in the middle. This product, similar to all-ceramic femoral heads, has a high surface hardness, low friction coefficient, low surface roughness, and excellent hydrophilic lubricity, which reduces wear and extends service life.

In addition, the zirconium-niobium alloy femoral head also provides the strength of metal prostheses due to its resistance to brittle fragmentation or release of ions, such as Co and Cr. This innovative material further reduces the wear rate of the joint surface, helping to increase the service life of the prosthesis whilst ensuring its safety to meet patients’ increasing demands.

Mr. Zixin Weng, President of MicroPort® Orthopedics, said, “This zirconium-niobium alloy femoral head, developed by MicroPort® Orthopedics, is created using a design concept that is the first of its kind in China. It is expected to improve patients’ post-operative satisfaction by extending the life of the hip prosthesis and reducing material wear. We will continue to optimize our product portfolio, with an aim of providing more total solutions for skeletal and muscle diseases to help more patients regain their health. ”

A hip prosthesis that is used in total hip replacement consists of an artificial femoral head and an artificial acetabulum. The service life of the prosthesis is critically related to the materialsm, as the material at the weight-bearing interface of the prosthetic joint wears down with the patient’s movements, generating various particles that are likely to cause complications, such as infection, fracture and loosening. Currently, metal and ceramic are the most popular materials for hip implants.

About MicroPort® Orthopedics

MicroPort® Orthopedics is a subsidiary of MicroPort Scientific Corporation (00853.HK). Underpinned by the core strengths of innovative design and industry-leading manufacturing capabilities, MicroPort® Orthopedics has provided a range of high-quality and affordable treatment solutions to patients in more than 60 countries and regions worldwide, offering joint products that have already benefited nearly 1.4 million patients globally to date. In addition to its medical pivot knee products, MicroPort® Orthopedics continues to develop innovative technologies to provide patients with high-quality total medical solutions.