Centric Medical: 510(k) for Subtalar Arthroereisis System

Centric Medical, a division of Life Spine, Inc. has announced 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.

As indicated in the June 23, 2016 news release, “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.”

Asked about the development process, Vice President of Strategic Planning at Life Spine, Inc. Omar Faruqi told OTW, “It was interesting to work with our design surgeons to understand their unmet needs, then taking that information to make products that potentially answer those unmet needs. Thereby potentially leading to better patients satisfaction and qualities of life.”

“By end of Q1 2017, Centric Medical will have launched 12 products consisting of: four First-in-Class Products including our currently released TARSA-LINK Stand-Alone Wedge Fixation System and three Best-in-Class Products.”