FDA 510(k) Clears Centric Medical’s Subtalar Arthroereisis Implant System

Centric Medical, a division of Life Spine Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the subtalar joint.
 
The Subtalar Arthroereisis Implant System is a one-piece titanium implant designed to facilitate correction of pathologic flatfoot deformities by blocking forward, downward and medial displacement of the talus, thus allowing normal articulation of the subtalar joint while deterring excessive pronation. The innovation of the system rests in its gradually softened threads which aid in minimizing edge effects that may lead to pain while resisting migration, in addition to being fully cannulated to guide accurate insertion.
 
The Subtalar Arthroereisis is the fourth 510(k) clearance in a year for Centric Medical and its suite of innovative osteobiologic products. It is one of seventeen patents pending in Centric’s portfolio including the groundbreaking TARSA-LINK Stand-Alone Wedge Fixation System, the first stand-alone Osteotomy wedge with built-in fixation on the market, which was released earlier this year. The Subtalar Arthroereisis Implant System is scheduled for limited release at the end of 2016 with full product release expected in the first quarter of 2017.