FDA grants clearance to device for treatment of challenging bone fractures

USA: Bone Bolt System, a new system for fixing bone fractures, has received 510(k) clearance approval from the U.S. Food and Drug Administration (FDA) to sell and market the device in the U.S. This milestone marks the first time that a novel medical device has received an FDA 510(k) clearance in University of Utah’s history.

The approval was announced by the University of Utah Orthopaedic Innovation Center (OIC), Department of Orthopaedics and Spencer Fox Eccles School of Medicine.

“This achievement demonstrates the commitment by the Department of Orthopaedics to bring new and innovative solutions to advance the quality of orthopaedic patient care,” said Darrel S. Brodke, M.D., Jack and Hazel Robertson Presidential Professor and chair of the Department of Orthopaedics. “It is the dynamic collaboration between our clinical faculty, trainees, our discovery research group and our innovation research group, known as the OIC, that led to this advancement, a first of many to come.”

“As one of the nation’s leading research universities, innovation plays a central role in our mission to improve the quality of life of our patients—OIC’s Bone Bolt System does just that,” said University of Utah President Taylor Randall. “Not only will the device make a difference in the care we can provide at University of Utah Health, but it illustrates our commitment to turn research into real-world impact by getting it to market as soon as possible, to improve health outcomes more broadly.”

The Bone Bolt System is a novel implant system designed and developed by the OIC for percutaneous bone fracture fixation. The system is a comprehensive set of implants of various lengths and diameters, along with associated surgical instruments and sterilization trays. The implants are used to treat challenging bone fractures, such as pelvic fractures and fractures of the long bones in the arm and leg. The Bone Bolt System is protected by U.S. Patent No. 11,553,948, with other U.S. and international patents pending.

The OIC submitted a 510(k) to the FDA to demonstrate that the medical device is safe and effective, or “substantially equivalent,” to an existing FDA 510(k) cleared device. Upon 510(k) clearance by the FDA, the medical device may be legally marketed in the U.S.

The OIC has developed the Bone Bolt System in full compliance with the FDA Quality System Regulations and ISO 13485 Medical Devices—Quality Management Systems. Additionally, the OIC has developed a commercial supply chain for the Bone Bolt System. The next step, to be led by the OIC and the University of Utah PIVOT Center, will be establishing industry partnerships to commercialize the Bone Bolt System and bring it to hospitals and surgery centers throughout the country for the benefit of orthopaedic patients.

“The simplicity of the Bone Bolt procedure to effectively stabilize complex fractures will impact the standard of care for patients with challenging fractures. The thoughtfulness during development of the Bone Bolt System encourages rapid adoption as the development team considered the care provider’s perspective in conjunction with clinical outcomes,” said PIVOT Associate Director of Innovation & Commercialization Huy Tran. “PIVOT Center is looking forward to engaging with potential industry partners to commercialize the technology and make an immediate impact on the quality of life for patients.”