On September 19th, following a review by the National Medical Products Administration (NMPA), JUST Medical's independently developed Xuanzuan® zirconia niobium alloy Femoral Head officially obtained the Medical Device Registration Certificate of the People's Republic of China. Against the backdrop of joint procurement of artificial joints, the booming market release of this product is expected to resolve the industry's bottleneck issue concerning core components.

As a national-level "specialized, sophisticated, and innovative" (SSI) small giant enterprise and a national high-tech enterprise, JUST Medical possesses two major innovation platforms: the Tianjin Enterprise Key Laboratory and the Tianjin Enterprise Technology Center. We have established a comprehensive research and development system integrating production, academia, research, medical services, and testing. Our focus is on the tiered diagnosis and treatment of musculoskeletal diseases, with a strong emphasis on researching new technologies, materials, and internationally competitive products.

In the research and development process of the Xuanzuan® zirconium niobium alloy femoral head, the dual-platform integration has played a crucial role in overcoming technological bottlenecks, promoting the transformation of achievements, and jointly building a comprehensive innovation chain for JUST Medical's technology.

Material Innovation——Zero Fracture, Zero Allergies, Low Magnetization.

The femoral head is a core component that affects the lifespan of artificial hip Joint Replacement. The material used for it should have high strength, wear resistance, and excellent biocompatibility. Currently, commonly used materials on the market include metals and ceramics. Metal materials have good biocompatibility and overall mechanical properties but suffer from metal ion release issues. Ceramic materials offer high strength, wear resistance, and low allergenicity but come with the risk of brittle fracture.

JUST Medical has conducted extensive research to address these clinical challenges. They use zirconium niobium material, which boasts excellent biocompatibility. The zirconium niobium surface is oxidized in situ to create a ceramic layer, combining the toughness of metals with the wear resistance of ceramics. This innovation aims to improve the rough surface of traditional metal femoral heads like Co-Cr and reduce wear between the femoral head and polyethylene.

1. 0 Fractures

The zirconium niobium alloy substrate retains the strength and toughness of metals. After 10 million cycles of fatigue testing under a load three times the body weight, the compressive failure force remains more significant than 90 kN. Compression tests confirm no risk of fractures.

2.0 Allergies

Compared to cobalt-chromium-molybdenum femoral heads, zirconium niobium alloy femoral heads exhibit excellent biocompatibility. In ion release tests and biocompatibility tests, zirconium niobium alloy femoral heads show 0 cytotoxicity and 0 metal allergy reactions, meeting the needs of more patients with metal allergies for joint replacement.

3. Low Magnetization

Compared to cobalt-chromium-molybdenum femoral heads, the zirconium-niobium alloy femoral head used in zirconium-niobium alloy femoral head has a lower magnetization due to the use of Zr and Nb. Among various Zr-xNb compositions, Zr-2.5Nb is in the lowest magnetization range of Zr-xNb materials, resulting in reduced MRI artifacts [1,2].

Technological Innovation——Breaking Through International Technological Bottlenecks

JUST Medical's Xuanzuan® zirconium niobium alloy femoral head undergoes high-temperature oxidation of the zirconium niobium alloy by controlling parameters such as time, temperature, and oxygen supply, creating a wear-resistant and non-detachable metal-ceramic. Under scanning electron microscopy, the product's ceramic surface, transition zone, and matrix cross-section can be clearly displayed.

The wear resistance of prostheses significantly impacts their lifespan. The volumetric wear rate of zirconium niobium alloy ceramic - highly cross-linked polyethylene is, on average 8 mm3/MC, which is much lower than the wear rate of cobalt-chromium-molybdenum - highly cross-linked polyethylene combinations (40-100 mm3/MC). This reduction in wear debris from highly cross-linked polyethylene lowers the risk of bone loosening and bone resorption. Additionally, the in-situ formed transition zone securely anchors the ceramic surface to the metal substrate, enhancing the bond between the ceramic surface and the substrate and preventing detachment.

JUST Medical has broken through industry barriers with its Xuanzuan® Zirconia-Niobium Alloy Femoral Head, addressing critical technical challenges that have previously hindered progress. By integrating related industry chains, JUST Medical is taking a significant step towards providing domestically produced metal-ceramic products, accelerating the development of high-end orthopedic implants in China.

In the future, JUST Medical will continue to optimize its innovation mechanisms through its two major innovation platforms. The company remains committed to its mission of providing doctors with safe, effective, and refined medical products and services, offering high-quality choices for orthopedic doctors and patients in clinical treatment.