Bone 02 Hits Another Milestone! Woman with Lumbar Disc Herniation Could Hardly Walk, Cured Without Metal Screws Using This Bone Adhesive

Crushed bone fragments can now be bonded with medical adhesive. Bone 02, the world’s first bone adhesive material developed by a Zhejiang medical team that delivers instant, powerful adhesion in the human blood-rich environment, has achieved another breakthrough. It has successively secured clearance under China’s Special Review Procedure for Innovative Medical Devices and U.S. FDA Breakthrough Device Designation, marking a pivotal step toward clinical application for this fully domestically researched and manufactured Chinese innovation.

Over 150 Patients Enrolled in Clinical Trials; Material Greatly Accelerates Bone Healing

Last year, the orthopedic team at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (SRRSH) unveiled this landmark homegrown innovation: a biomaterial capable of bonding and fixing bone fragments of all sizes.

Professor Fan Shunwu, Director of the Department of Orthopedics at SRRSH, explained that complex orthopedic cases such as comminuted fractures and age-related fragility fractures have long relied on metal internal fixation. This method brings large surgical trauma, lengthy recovery periods, and high risks of complications including fixation loosening and surgical site infection. For decades, the global orthopedic field has struggled to develop viable bone adhesives, held back by two core technical bottlenecks: insufficient biological safety and weak adhesive force in blood-filled environments. Generations of orthopedic surgeons have long dreamed of repairing broken bones with glue — a goal now realized.

After a decade of intensive research, the orthopedic R&D team at SRRSH successfully overcame key technical hurdles to develop Bone 02 bone adhesive. The material rapidly bonds bone fragments under the body’s moist physiological environment with stable bonding strength. It gradually degrades naturally as new bone regenerates and is fully replaced by autologous osseous tissue, triggering a revolutionary shift in fracture treatment from mechanical metal fixation to biological adhesion.

To date, Bone 02 has completed the world’s first multicenter randomized controlled trial (RCT) for bone adhesive fracture therapy across multiple top-tier medical institutions, including the Second Affiliated Hospital of Zhejiang University School of Medicine, Shanghai Sixth People’s Hospital (National Center for Orthopedics), and the First Affiliated Hospital of University of Science and Technology of China. More than 150 randomized controlled clinical cases have been fully enrolled, followed up and completed.

Trial data reveals striking advantages versus the control group: drastically reduced incidence of fracture displacement, over 50% shorter intraoperative bone fragment fixation time, substantially enhanced surgical safety, accelerated bone union, and shortened patient rehabilitation cycles.

In January 2026, Bone 02 entered the Special Review Procedure for Innovative Medical Devices administered by China’s National Medical Products Administration (NMPA). In April the same year, it was awarded FDA Breakthrough Device Designation.

Industry experts noted this marks the first time a Chinese original orthopedic device has obtained dual regulatory recognition from top Chinese and U.S. medical regulators, proving domestic high-end medical devices now possess robust competitiveness in global cutting-edge medical technology.

Surgeon demonstrating the adhesive performance of Bone 02

Patient Could Barely Walk from Lumbar Disc Herniation; Ambulatory Within Three Postoperative Days

The R&D team continues expanding clinical applications, launching exploratory clinical trials of Bone 02 for spinal surgery and dental implants.

Traditional lumbar fusion surgeries require implantation of multiple pedicle screws, which demand extensive soft tissue dissection, trigger heavy intraoperative blood loss, and raise risks of screw-related surgical complications. Bone 02 pioneers a minimally invasive fusion alternative: biological bonding replaces mechanical screw fixation to achieve stable fusion of bone graft zones. Preliminary clinical data shows patients experience marked relief of lumbar symptoms post-operation, with superior fusion outcomes and long-term functional recovery compared to conventional screw-based procedures.

For dental implant patients with severe alveolar bone loss who cannot undergo immediate or primary implant surgery, early exploratory clinical research confirms Bone 02 delivers exceptional interfacial adhesion to bone tissue and robust in-vivo osteogenic potential, opening new avenues for broader clinical adoption of this technology.

Ms. Wang, a patient in her 40s, is one of Bone 02’s beneficiaries. She suffered recurrent lower back pain from lumbar disc herniation three years ago, which progressed to radiating pain in her left hip and left leg last year. “The pain was so severe I could not walk on my left foot.”

She sought treatment at SRRSH’s Orthopedics Department last year. Physical examinations and imaging confirmed her lumbar disc herniation was compressing nerve roots. To permanently resolve nerve compression, the medical team performed Transforaminal Lumbar Interbody Fusion (TLIF) at the L4/5 segment.

This standard spinal surgery precisely relieves nerve root compression and restores lumbar stability to alleviate lower back and leg pain. Conventional lumbar fusion relies on pedicle screw fixation to strengthen spinal stability and prevent interbody cage dislocation.

“My doctor asked if I wanted to join the Bone 02 clinical trial. I initially worried the adhesive might not hold firmly, yet I refused to have metal screws implanted in my lumbar spine, so I decided to participate,” Ms. Wang shared. She expressed relief over her choice: “I could walk on my own three days after surgery, and the leg pain vanished. Within two to three weeks, I fully resumed normal daily life at home.”

Associate Chief Physician Lin Xianfeng, Deputy Director of Orthopedics and lead researcher of the Bone 02 development team, stated that multiple hurdles remain before the innovation can reach widespread patients, including scaled-up manufacturing, global multicenter clinical trials, and worldwide market access. Moving forward, the R&D team will leverage the platforms of Zhejiang University and SRRSH to fully cooperate with NMPA and relevant regulatory authorities, accelerating clinical translation and commercial launch of the product to benefit millions of fracture patients.

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