Novel Implant System Effectively Treats Challenging Bone Fractures

The Bone Bolt System is a novel implant system for percutaneous bone fracture fixation that has been designed and developed by the Orthopedic Innovation Center (OIC) at the University of Utah (Salt Lake City, UT, USA). The system comprises a comprehensive kit of implants of various lengths and diameters, along with related surgical tools and sterilization trays. The implants are used to treat complex bone fractures, such as those in the pelvis and long bones in the arms and legs. The Bone Bolt System has received 510(k) clearance from the US FDA, permitting its sale and marketing in the U.S. and marking the first such clearance for a novel medical device in the history of the University of Utah.

The Bone Bolt System has been developed by the OIC in strict compliance with the FDA Quality System Regulations and ISO 13485 Medical Devices—Quality Management Systems. Furthermore, the OIC has established a commercial supply chain for the Bone Bolt System. Going forward, the Bone Bolt System will be commercialized through industry partnerships for distribution to hospitals and surgical centers across the U.S., thereby benefiting orthopedic patients.

“The simplicity of the Bone Bolt procedure to effectively stabilize complex fractures will impact the standard of care for patients with challenging fractures,” said PIVOT Associate Director of Innovation & Commercialization Huy Tran. “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.”

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