Sonoma Receives 510(k) FDA Clearance for the Minimally-Invasive FibuLock™ Nail for Ankle Fracture Repair (press release)
BUFFALO GROVE, Ill., Feb. 13, 2015 /PRNewswire/ -- Sonoma Orthopedic Products (Sonoma), a medical device manufacturer specializing in minimally-invasive bone fracture repair, has received FDA 510(k) clearance for the intramedullary (within the bone canal) FibuLock™ Nail that offers physicians a new alternative in the way they surgically treat ankle fractures.
Fractures of the lower end of the fibula are one of the most common ankle fractures seen in hospitals. These injuries are predominantly surgically repaired with plates which allow surgeons to anatomically realign most fractures and stabilize the ligaments through a four to six-inch incision. This alignment is critical in ankle fractures to prevent the development of arthritis. A plate aligns the fracture by being screwed to the outside of the broken bones just under the skin. Due to the proximity to the skin, roughly 30% of patients complain about plate discomfort and frequently request a second surgery for removal. Additionally, surgeons are often concerned the large incisions necessary to implant plates ca...
