(ECNS) -- A China-developed bone adhesive has been granted fast-track designations by both China and the United States, marking a first for a domestic orthopedic device.
The product, known as Bone Adhesive "Bone 02," entered the National Medical Products Administration (NMPA) Innovation Medical Device Special Review Procedure in January 2026 and received Breakthrough Device designation from the U.S. Food and Drug Administration in April, according to Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine.
The adhesive is designed to address long-standing challenges in orthopedic surgery. Complex fractures, including comminuted and fragility fractures, have traditionally relied on metal implants, which can involve significant surgical trauma, long recovery periods and risks of loosening and infection.
Previous efforts to develop bone adhesives have been limited by insufficient biosafety and weak adhesion in bloody surgical environments.
After a decade of research, the team developed an adhesive of bonding bone fragments quickly and securely in wet in-vivo conditions. The material naturally degrades over time and is fully replaced by new bone tissue.
Clinical data from a randomized controlled trial involving more than 150 patients showed that the adhesive significantly reduced fracture displacement, cut bone fixation time in operating rooms by more than half, shortened recovery periods and improved surgical safety. Multi-center clinical studies have been completed at several major hospitals.
The team is now exploring potential applications in spinal surgery and dental implants.
The fast-track designations will allow the product to receive priority review and regulatory guidance from the two agencies. However, challenges remain in scaling up manufacturing, conducting international clinical trials and securing global market access, according to Lin Xianfeng, head of the research team.
(By Tang Yuxian)
京公网安备 11010202009201号