June 23, 2016
HUNTLEY, Ill.–(BUSINESS WIRE)–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.
About Centric Medical
Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.
for Centric Medical
Mr. Omar Faruqi
Chief Financial Officer