FDA grants 510(k) clearance for Sonoma’s FibuLock Nail for ankle fracture repair

15 February 2015 (Last Updated February 15th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sonoma Orthopedic Products' intramedullary (within the bone canal) FibuLock Nail, which offers physicians a new alternative to surgically treat ankle fractures.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sonoma Orthopedic Products' intramedullary (within the bone canal) FibuLock Nail, which offers physicians a new alternative to surgically treat ankle fractures.

The device uses a less-invasive approach to surgically treat ankle fractures with plates, and offers anatomic ligament stabilisation.

Fractures of the lower end of the fibula are predominantly surgically repaired with plates, which allow surgeons to anatomically realign most fractures and stabilise ligaments through a 4in-6in incision.

The new device can be implanted into the fibula through a small incision less than an inch long, and the nail is inserted within the bone canals, after the surgeon aligns the broken bones.

Following alignment of the broken bones, FibuLock anchors are activated to stabilise the fracture for healing.

"The device uses a less-invasive approach to surgically treat ankle fractures with plates, and offers anatomic ligament stabilisation."

In addition, the device is expected to reduce the incidence of secondary removal surgeries because FibuLock is inside the bone, which does not create discomfort associated with plates.

San Diego-based orthopaedic surgeon Dr Robert Tonks said: "I have been using intramedullary devices for 20 years to repair ankle fractures due to their capacity to avoid wound issues and expedite patient rehabilitation.

"However, these devices are basically metal rods with screws at their lower end to stabilise fractures. Half of fractures are above these screws, and the rods are not applicable.

"Furthermore, these rods have simplistic surgical instruments that make it difficult to align a fracture compared to a plate.

"The FibuLock Nail features internal bone anchors which allow alignment and support of any operable fracture including higher fibula fractures. In addition, the instruments are expressly designed to anatomically realign the bones."

The company intends to launch FibuLock Nail in select geographies in the second quarter of 2015.