Sonoma Orthopedic Products received FDA 510(k) clearance for the intramedullary FibuLock Nail.
The implant offers physicians a new alternative in the way they surgically treat ankle fractures. The nail is designed to treat the same fractures as plates, as well as provide for anatomic ligament stabilization, but with a less-invasive approach.
"Nails have already replaced plates as the gold standard for repairing fractures in the femur and tibia because nails are less-invasive and deliver fewer postoperative complications with faster rehabilitation," said Rick Epstein, CEO of Sonoma. "However, developing a nail for the fibula is difficult due to its small size and unique geometry. Until the FibuLock, there wasn't a device that could deliver the stability, versatility and effectiveness of plates. Now, our technology will allow surgeons to bring the advantages of nailing to ankle fracture patients."
More articles on devices:
7 key trends in joint replacement customization
Amedica files FDA application for spinal implant spacers with porous silicon nitride center — 6 things to know
Revenue up, $147k net loss — 10 key points on RTI Surgical's 2014 financial report