- Injectable adhesive could replace screws and metal plates in some fractures
- Developers say product works in blood-filled surgical environments
A surgical adhesive developed by researchers at Sir Run Run Shaw Hospital in Hangzhou has received breakthrough-device recognition from both Chinese and US regulators, marking a potential advance in fracture treatment that could reduce reliance on metal screws and plates.
The product, known as “Bone 02,” was granted innovative medical device certification by China’s National Medical Products Administration and breakthrough device designation by the US Food and Drug Administration, according to the orthopedic team at the hospital, which is affiliated with Zhejiang University School of Medicine.
Fracture treatment for complex breaks has relied for more than a century on metal fixation devices such as plates and screws.
But those methods can involve significant surgical trauma, slower recovery times and risks including loosening and infection. Small bone fragments are often difficult or impossible to secure mechanically.
Researchers have long sought medical adhesives capable of bonding bone safely inside the body, but progress has been hindered by two major challenges: biocompatibility and maintaining adhesion in wet, blood-filled environments.
Inspired by oysters
The Zhejiang University team said it drew inspiration from oyster reef formation, in which oysters secrete adhesive substances that remain firmly attached underwater. That mechanism helped researchers develop a material capable of rapid and strong bonding during surgery.
In demonstrations, doctors mixed two adhesive components and injected the material into fracture sites, where it solidified within one to three minutes.
Fan Shunwu, head of orthopedics at Sir Run Run Shaw Hospital, said the technology represents a shift away from traditional rigid fixation toward biological adhesion.
“Metal fixation relies on hard mechanical force, while bone glue uses biological bonding,” Fan said. “It is minimally invasive and especially effective for tiny bone fragments that are difficult to treat with conventional methods.”
According to multicenter clinical studies involving more than 150 patients, Bone 02 significantly reduced fracture displacement rates, cut fixation time during surgery by more than half and shortened healing and rehabilitation periods.
Dental potential
Researchers said the adhesive has also shown potential in other procedures, including dental bone reconstruction and spinal fusion surgery.
In lumbar fusion operations using the adhesive instead of conventional screw fixation, some patients were able to walk by the third day after surgery, while complication risks were reduced, the team said.
Cai Xiujun, president of Sir Run Run Shaw Hospital and a member of the Chinese Academy of Sciences, said the dual recognition from Chinese and US regulators places the product on an accelerated approval pathway.
“We will work closely with regulators to speed up commercialization so fracture patients can benefit as soon as possible,” Cai said.
