Medical device firm Sonoma Orthopedic Products has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its FibuLock Nail, designed to provide physicians with a new alternative to treat ankle fractures.
Using a much less-invasive approach, the new intramedullary (within the bone canal) device surgically treats ankle fractures with plates, as well as to provide anatomic ligament stabilization.
Sonoma Orthopedic Products CEO Rick Epstein said: "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.
"Until the FibuLock, there wasn’t a device that could deliver the stability, versatility and effectiveness of plates."
The device can be implanted into the fibula through a small incision less than an inch long, and is inserted within the bone canals, after the surgeon aligns the broken bones.
Sonoma noted that the FibuLock anchors are then activated, which are said to stabilize the fracture for healing.
In addition, the device is expected to reduce the incidence of secondary removal surgeries, as FibuLock will be inside the bone that does not create the discomfort associated with plates.
The company intends to launch the new product in select geographies in the second quarter of this year.
Image: Sonoma has received FDA approval for FibuLock Nail to treat ankle fractures. Photo: courtesy of Somkiat Fakmee/ FreeDigitalPhotos.net.