FDA grants 510(k) clearance of novel percutaneous bone fracture fixation system
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Key takeaways:
- The University of Utah Orthopaedic Innovation Center has announced FDA clearance of its Bone Bolt system.
- The system is designed for fixation of pelvic, arm and leg fractures.
The University of Utah Orthopaedic Innovation Center has announced FDA 510(k) clearance of its Bone Bolt fracture fixation system, according to a press release.
The University of Utah Orthopaedic Innovation Center (OIC) is working to commercialize the Bone Bolt system, which consists of different-sized implants, instruments and sterilization trays, according to the release. The system can be used for the fixation of pelvic, arm and leg fractures.
“This achievement demonstrates the commitment by the department of orthopedics to bring new and innovative solutions to advance the quality of orthopedic patient care,” Darrel S. Brodke, MD, Jack and Hazel Robertson Presidential Professor and chair of the department of orthopedics at the University of Utah, said in the release. “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,” Brodke said.
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