On May 21st, Shao Yifu Hospital affiliated to Zhejiang University School of Medicine announced that the world's first bone glue "Bone 02" has been approved by China's special review procedure for innovative medical devices and the US FDA's breakthrough device designation. This Chinese original achievement, inspired by ancient craftsmen's method of using oysters to strengthen bridge foundations, has turned the dream of "gluing bones with glue" into a tangib
She Huimin 2026-05-25 06:51:40
Imagine that after a fracture, you don't need the traditional "100 days for bones and tendons to heal" — a single injection of "bone glue" can firmly adhere the broken bones. This scenario from science fiction is gradually becoming a reality.
On May 21, Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine announced that the world's first bone glue, "Bone 02", has successively been approved for China's Special Review Procedure for Innovative Medical Devices and the U.S. FDA Breakthrough Device Designation. This original Chinese achievement, inspired by ancient craftsmen who used oysters to reinforce bridge foundations, turns the dream of "gluing bones together" into a tangible reality.
The approval of "Bone 02" signifies that the orthopedic treatment paradigm will undergo a fundamental shift from "rigid fixation" to "biological healing".
Traditional fracture treatment relies on metal internal fixators such as steel plates and screws, resulting in large surgical trauma and long recovery periods, and patients also have to endure the pain of a second surgery for removal. The research and development of bone glue, which has plagued the global orthopedic community for many years, has long been stagnant due to two major technical bottlenecks: insufficient biosafety and weak adhesion in blood environments.
However, China's independently developed "Bone 02" bone glue has successfully broken through these two bottlenecks. "Bone 02" is injected through a 2 cm to 3 cm minimally invasive incision and can achieve immediate and strong adhesion in a blood-infiltrated wet environment within 2 to 3 minutes, with a maximum adhesive tensile strength of over 400 jin (approx. 200 kg). The material naturally degrades and is absorbed as the bone heals over several months, being completely replaced by new bone tissue. This leap from "mechanical fixation" to "biological adhesion" solves the clinical pain point of difficult fixation of small bone fragments in comminuted fractures, greatly improving surgical efficiency, and can also significantly enhance surgical safety, promote fracture healing, and shorten the patient's recovery cycle.
The clinical application value of "Bone 02" goes beyond routine fracture treatment. In the fields of spinal lumbar fusion surgery and dental implant surgery for elderly patients in dentistry, "Bone 02" has unique advantages of minimal trauma, fast recovery, and low difficulty. In addition, due to its rapid adhesion and ease of use, "Bone 02" can also be used for emergency treatment of fractures in special scenarios such as national defense and disaster rescue.
"Bone 02" has successively obtained dual "innovation" channel designations from China and the U.S., and its commercial value is already clear.
According to clinical estimates, there are approximately tens of millions of new comminuted fracture patients worldwide each year, and the orthopedic medical device market is huge. As the world's first bone glue material capable of achieving immediate and strong adhesion in the human blood environment,
"Bone 02" possesses significant first-mover advantages and technological barriers.
"Bone 02" is not only expected to replace part of the traditional metal internal fixator market, but is also likely to open up a completely new orthopedic treatment track. Core competitiveness such as minimally invasive, no second surgery, and fully biodegradable gives it natural advantages in reducing patient suffering and lowering medical costs. With the implementation of the dual innovation channel designations from China and the U.S., its internationalization process will accelerate, and it is expected to seize the commanding heights of the global orthopedic biomaterial market, forming a complete industrial ecosystem of "R&D—Production—Clinical—Export", and becoming a benchmark product for domestic high-end medical devices going global.
The significance of "Bone 02" lies not only in a single technological breakthrough, but also in that it demonstrates a feasible path for Chinese original medical devices to go global.
High-end medical devices are an important indicator of a country's scientific and technological strength. For a considerable period of time, China faced "chokehold" bottlenecks in core technologies in this field, with products mostly being low-to-mid-end imitations, and high-end products often relying on imports.
The success of "Bone 02" breaks the foreign technological monopoly in the field of high-end orthopedic devices, marking that domestic high-end medical devices are moving from "following" to "running alongside" and even "leading", proving that China is fully capable of achieving original leadership in the field of cutting-edge medical technology.
At the same time, the R&D path of "Bone 02" also provides valuable experience for China's medical device innovation: adhering to clinical orientation, strengthening industry-university-research collaboration, and focusing on core technology breakthroughs will truly break through barriers and grasp the initiative for development.
A small bone glue carries the original aspiration of medical progress and demonstrates the confidence of independent innovation. Looking to the future, we look forward to more domestic high-end medical devices, represented by "Bone 02", standing out and demonstrating the strength and responsibility of China's intelligent manufacturing in the international market.
