TechMed Group's Innovative Biodegradable Magnesium Alloy Bone Screw Receives NMPA Approval, Pioneering a Global Orthopedic Revolution

On April 11, 2025, China’s biomaterials field witnessed another significant milestone: the biodegradable magnesium alloy bone fixation screws, independently developed by Huarong Kechuang Biotechnology (Tianjin) Co., Ltd., successfully received the Medical Device Innovation Approval from the National Medical Products Administration (NMPA).

 Link to the National Medical Products Administration (NMPA) public notice:

https://www.cmde.org.cn/xwdt/shpgzgg/cxyxgsh/20250326091237185.html

As the first biodegradable magnesium alloy product in China to receive approval for an innovative medical device, its core raw material formulation has been granted PCT invention patents in both China and the United States. The approval of this innovative device not only serves as a “national team certification” of HuaRong KeChuang’s technical prowess in overcoming key challenges, but also reflects the National Medical Products Administration’s high recognition of the company’s innovation in new products and materials, as well as their clinical value. This milestone signifies that the “R&D innovation and internationally leading” technological level of biodegradable magnesium alloy materials has received authoritative national-level endorsement, demonstrating that the company’s R&D and innovation capabilities in this field have undergone rigorous evaluation by national-level professional institutions and experts.

After five years of collaborative efforts, Huarong Chuangke has engaged in deep industry-academia-research cooperation with the School of Materials Science and Engineering at Central South University. Actively responding to the strategic deployment of China’s National 863 Program in the field of new material technologies, the company has successfully established a full-chain R&D system encompassing “original material formulation development—laboratory validation—animal experimental validation—clinical application translation.” The core advantages of the biodegradable magnesium alloy bone screws include:

 ▲ Advantages of Huarong Kechuang Biodegradable Magnesium Alloy Bone Screws

Clinical trial results led by the National Clinical Research Center for Orthopedics at Shanghai Sixth People's Hospital indicate thatOver one hundred clinical trial participants underwent successful surgical procedures. All patients achieved complete healing after implantation of magnesium alloy screws, with no related adverse events reported. Follow-up imaging consistently demonstrated satisfactory fracture healing and no screw displacement. The concentrations of ions released during screw degradation remained stable and within safe limits acceptable for the human body. Both the efficacy and safety of the product have been clinically validated. The clinical procedure is simple and convenient, requiring no changes to existing technical workflows, thereby simultaneously enhancing operational convenience for physicians and patient safety.

As a milestone technological breakthrough in China’s biomaterials sector, the approval of Huarong Kechuang’s biodegradable magnesium alloy bone fixation screws has ushered in a systemic transformation spanning materials research and development, industrial ecosystems, and healthcare delivery models.

● Breaking Through National Strategic Impasses: Actively responding to the national 863 Program’s strategic deployment in the field of new material technologies, and leveraging its globally exclusive patented magnesium alloy formulation to develop degradable metallic implants, thereby driving the biomedical materials industry toward “internationally leading intelligent manufacturing”;

● Industry Ecosystem Innovation: As a new generation of absorbable materials, biodegradable magnesium alloys will bring about a tremendous transformation in clinical applications. This breakthrough technology will leverage the restructuring of the global medical materials market, valued at hundreds of billions, and usher in a new wave of revolution in orthopedic treatment;

● Medical Technology Revolution: Biodegradable magnesium alloys are ushering in a technological revolution in fracture healing, shifting the paradigm from “passive waiting for healing” to “active promotion of bone regeneration.” Magnesium ions facilitate the adhesion and proliferation of osteoblasts and exert osmotic pressure on bacteria to inhibit their growth. This represents a revolutionary advancement in both fracture healing and anti-infection capabilities;

● Enhanced Patient Benefits: Avoids the risk of secondary surgery, significantly reduces physical and psychological burden, and lowers medical costs.

Material innovation, as the core driver of the medical device industry’s development, has always been at the forefront of industry transformation. The recent approval of Kechuang Medical Group’s independently developed biodegradable magnesium alloy bone screws marks a key breakthrough in the company’s strategic layout in the field of biomaterials. Looking ahead, Kechuang Medical will use this achievement as a new starting point to further accelerate the translation of scientific and technological innovations in raw materials into practical applications. Leveraging its strong independent R&D capabilities, Kechuang Medical is committed to leading the clinical application of next-generation biodegradable materials worldwide, injecting new vitality into the development of the medical device industry and driving the sector to new heights.