The FDA has approved Sonoma Orthopedic Products’ FibuLock Nail device for the repair of ankle fractures.
Sonoma said FibuLock is designed to be a less invasive and more comfortable alternative to traditional surgical plates, which are screwed directly onto the bone through a large incision. In comparison, FibuLock Nails are inserted through a small incision directly into the bone canal.
Sonoma added the nails provide a safer option for patients with poor leg circulation, such as diabetics, who are at higher risk of developing chronic infections from leg incisions.
The company plans to launch the product in certain locations during the second quarter.
“Nails have already replaced plates as the gold standard for repairing fractures in the femur and tibia (thigh and shin bones) because nails are less-invasive and deliver fewer post-operative complications with faster rehabilitation,” said Sonoma CEO Rick Epstein, in a release. “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.”
In December, Sonoma raised $12 million from First Analysis for its “flexible-to-rigid” ankle implants.