The University of Utah Orthopaedic Innovation Center (OIC), in collaboration with the Department of Orthopaedics and Spencer Fox Eccles School of Medicine, announces that their Bone Bolt System has been granted market approval by the U.S. FDA.
The FDA’s 510(k) clearance marks a milestone for the University of Utah as it is the first time a novel medical device has received such clearance. The Bone Bolt System, designed and developed by the OIC, is a comprehensive implant system specifically created for percutaneous bone fracture fixation. With a range of implants in varying lengths and diameters, along with surgical instruments and sterilization trays, the Bone Bolt System addresses the treatment of challenging fractures, including pelvic fractures and long bone fractures in the arm and leg.
“We are proud of this achievement, which exemplifies our dedication to advancing orthopaedic patient care through innovation,” says Darrel S. Brodke, MD, chair of the orthopedics department. “The collaboration between our clinical faculty, trainees, and research groups has resulted in this groundbreaking advancement, the first of many to come.”
University of Utah President Taylor Randall emphasizes the importance of innovation in their mission to enhance patients’ quality of life, stating: “OIC’s Bone Bolt System not only enhances the care we provide at University of Utah Health but also demonstrates our commitment to translating research into tangible impact for improved health outcomes.”
The Bone Bolt System, protected by U.S. Patent No. 11,553,948, underwent rigorous evaluation to demonstrate its safety and effectiveness, establishing its substantial equivalence to existing FDA-cleared devices. In compliance with FDA Quality System Regulations and ISO 13485 Medical Devices—Quality Management Systems, the OIC has ensured adherence to stringent standards.
The OIC, in collaboration with the University of Utah PIVOT Center, will now focus on establishing industry partnerships to facilitate the commercialization and distribution of the Bone Bolt System to hospitals and surgery centers nationwide.
“The simplicity of the procedure and the consideration for care providers’ perspective and clinical outcomes make this technology a game-changer for stabilizing complex fractures,” says Huy Tran, PIVOT associate director of innovation and commercialization.
