Zhejiang University’s Original World’s First Bone Glue Receives Dual Innovation Recognition in China and the U.S., Expanding Dental Implantation Applications.

Image source: Sir Run Run Shaw Hospital, Zhejiang University

DentalGoodNews｜On May 21, 2026, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (hereinafter referred to as "SRRSH") announced that the world's first bone glue "Bone 02," originally developed by its orthopedic research team, has successively been granted the China Innovative Medical Device Special Review Procedure and the FDA Breakthrough Device Designation in the United States. SRRSH stated that this marks the first time a Chinese original orthopedic device has received dual recognition from both Chinese and American regulatory authorities.

According to SRRSH President Cai Xiujun, the dual "innovation" channel designation for "Bone 02" signifies that domestic high-end medical devices are transitioning from "following" to "leading." The product was developed by the SRRSH orthopedic research team after a decade of scientific research, aiming to address clinical pain points such as significant trauma, slow recovery, and numerous complications associated with traditional metal internal fixation.

Treatment of comminuted femoral fracture with bone cement-assisted plate and screw fixation

Clinical data shows that "Bone 02" has completed the world's first multi-center clinical study on bone glue for fracture treatment at institutions including the Second Affiliated Hospital of Zhejiang University School of Medicine and Shanghai Sixth People's Hospital. The cumulative 150+ randomized controlled trials (RCTs) indicate that, compared to the control group, the fracture displacement rate using this product was significantly reduced, the intraoperative fixation time for fracture fragments was shortened by more than half, and fracture healing was effectively promoted.

On the technical level, SRRSH stated that "Bone 02" has overcome two technical bottlenecks: insufficient biosafety and weak adhesion in wet in vivo environments. It can rapidly bond bone fragments in the body's wet environment and naturally degrade and be replaced as new bone grows. Currently, the research team is expanding the clinical application of "Bone 02" in spinal surgery and the field of dental implants. In the dental implant field, the team stated that for patients unable to undergo immediate implantation or one-stage implantation due to insufficient alveolar bone volume, preliminary exploratory clinical studies have shown its bone tissue interface bonding ability and in vivo osteogenic potential.

Notably, the head of the SRRSH orthopedic research team stated that the dual designations indicate the product has entered the fast track for priority review. In the future, the team will advance large-scale production, international multi-center clinical studies, and global market access to accelerate the clinical translation process.