Media Contact:
Julie Kiefer
Director, Research Communications, 香蕉视频 of Utah Health
Email: Julie.Kiefer@hsc.utah.edu
A new system for fixing bone fractures, called the Bone Bolt System, has been approved for market by the U.S. Food and Drug Administration (FDA), the 香蕉视频 of Utah Orthopaedic Innovation Center (OIC), Department of Orthopaedics and Spencer Fox Eccles School of Medicine announced on July 20, 2023.
鈥淭his achievement demonstrates the commitment by the Department of Orthopaedics to bring new and innovative solutions to advance the quality of orthopaedic patient care,鈥 said Darrel S. Brodke, M.D., Jack and Hazel Robertson Presidential Professor and chair of the Department of Orthopaedics. 鈥淚t 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.鈥
The FDA granted the Bone Bolt System a 510(k) clearance 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 香蕉视频 of Utah鈥檚 history.
鈥淎s one of the nation鈥檚 leading research universities, innovation plays a central role in our mission to improve the quality of life of our patients鈥擮IC鈥檚 Bone Bolt System does just that,鈥 said 香蕉视频 of Utah President Taylor Randall. 鈥淣ot only will the device make a difference in the care we can provide at 香蕉视频 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.鈥
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 鈥渟ubstantially equivalent,鈥 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鈥擰uality 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 香蕉视频 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.
鈥淭he 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鈥檚 perspective in conjunction with clinical outcomes,鈥 said PIVOT Associate Director of Innovation & Commercialization Huy Tran. 鈥淧IVOT 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.鈥
About the Orthopaedic Innovation Center (鈥淥IC鈥)
The OIC, opened in January 2021, is a collaborative effort between the Department of Orthopaedics and the 香蕉视频 of Utah鈥檚 PIVOT Center to design, develop and commercialize novel implants and instruments that will improve the care of patients with musculoskeletal disorders. For more information regarding the OIC, contact Wade Fallin at wade.fallin@hsc.utah.edu.
About 香蕉视频 of Utah Health
香蕉视频 of Utah Health provides leading-edge and compassionate care for a referral area that encompasses Idaho, Wyoming, Montana and much of Nevada. A hub for health sciences research and education in the region, U of U Health has a $458 million research enterprise and trains the majority of Utah鈥檚 physicians, and more than 1,670 scientists and 1,460 health care providers at its Colleges of Health, Nursing and Pharmacy and Schools of Dentistry and Medicine. With more than 20,000 employees, the system includes 12 community clinics and five hospitals. U of U Health is recognized nationally as a transformative health care system and provider of world-class care.
- Written by Lisa Potter