World's First Bone Adhesive "Bone 02" Receives China-U.S. Innovation Channel Approvals

Background

Comminuted fractures, in which a bone shatters into multiple small fragments, have presented persistent challenges in orthopedic treatment. Traditional approaches rely on mechanical fixation with metal plates, screws and other implants. These methods frequently require larger surgical incisions, increase risks of infection or foreign-body reaction, and often necessitate a second operation to remove hardware after healing. Precise alignment of numerous tiny bone fragments can be especially difficult and time-consuming under such conditions.

What was achieved

The orthopedic team at Sir Run Run Shaw Hospital independently developed an injectable biomaterial known as Bone 02, described as the world's first bone adhesive capable of strong bonding in wet, bloody physiological environments. In September 2025, the hospital and collaborating institutions including the Second Affiliated Hospital of Zhejiang University, Shanghai Sixth People's Hospital (National Orthopedics Medical Center) and the First Affiliated Hospital of the University of Science and Technology of China completed the world's first multicenter randomized controlled clinical trial of bone adhesive treatment for comminuted fractures. More than 150 patients participated, with all cases completing follow-up. Results indicated that, compared with controls, Bone 02 was associated with significantly lower rates of fracture displacement, intraoperative bone fragment fixation time shortened by more than half, improved surgical safety, enhanced fracture healing and shortened recovery periods.

On May 21, 2026, at a press conference held by the hospital, President Cai Xiujun announced that Bone 02 had been designated under China's National Medical Products Administration (NMPA) Innovative Medical Device Special Review Program in January 2026 and received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in April 2026. Reports described this as the first time an original Chinese orthopedic device achieved dual innovation channel recognitions from both regulatory bodies.

How it works

In surgery for a comminuted fracture, such as a shattered distal radius, surgeons traditionally expose the site and use metal hardware to hold fragments in place. With Bone 02, the procedure begins with a small 2-3 centimeter minimally invasive incision. The material, consisting of a powder and liquid component that are mixed at the time of use, is injected or applied directly to the fracture interfaces. Within 2-3 minutes, even in the presence of blood and moisture, it achieves rapid, strong adhesion. Laboratory data reported a maximum tensile bonding strength exceeding 400 pounds, shear strength of approximately 0.5 MPa and compressive strength of about 10 MPa.

The adhesive holds bone fragments in position to support healing. Its core components are derived from natural constituents of human bone tissue. Over approximately six months, as new bone forms and integrates, the material is fully biodegraded and absorbed by the body, eliminating the need for a secondary removal surgery. This approach represents a shift from purely mechanical fixation toward biological bonding that aims to reduce surgical trauma and support more precise fragment alignment.

What it means for international patients

The dual regulatory designations place Bone 02 on accelerated review pathways in both China and the United States, potentially shortening the time to broader clinical availability for treatment of comminuted fractures and related applications such as spinal fusion and oral implant procedures. For international patients, this could eventually mean access to a less invasive option that may reduce operative time, lower certain complication risks associated with permanent metal implants, and avoid secondary surgery.

Sir Run Run Shaw Hospital operates a dedicated International Healthcare Center, the first in Zhejiang Province with independent facilities for such services. The center has provided care to approximately 78,000 patients from more than 100 countries and regions. It features English-proficient staff, electronic translation devices supporting 85 languages, and follows an international-standard general practice model backed by the hospital's specialties. Patients interested in Bone 02 or related orthopedic care should contact the International Healthcare Center directly to confirm current eligibility, availability, regulatory status for their specific case, and any requirements for participation in studies or early access programs.

About the hospital

Sir Run Run Shaw Hospital, also known as Zhejiang University School of Medicine Affiliated Sir Run Run Shaw Hospital, is a public tertiary Grade A hospital located in Hangzhou, Zhejiang Province, China. It was established in 1994 through a donation by Hong Kong philanthropist Sir Run Run Shaw with support from the Zhejiang Provincial Government and initial collaboration with Loma Linda University Health in the United States.

The hospital is recognized for minimally invasive medicine across multiple disciplines and maintains Orthopedic Surgery as one of its National Clinical Key Specialties. The orthopedics department, established in 1994, focuses on spinal microsurgery, sports medicine, and reconstructive procedures, including techniques such as OLIF. It has been rated A++ (top 1 percent nationally) in the national tertiary public hospital performance evaluation for five consecutive years and ranked ninth in the 2022 assessment. The hospital was the first in China to achieve JCI accreditation and Magnet recognition and is the first Chinese member of the Mayo Clinic Care Network. Its International Healthcare Center serves global patients.