The device is a 1-piece titanium implant designed to block forward, downward and medial displacement of the talus to allow normal articulation of the subtalar joint. The device is slated for limited release at the end of this year, with a full product launch expected in the 1st quarter of 2017, the company said.
Huntley, Ill.-based Centric said the clearance is the 4th it’s won in a year from the federal safety watchdog.
Life Spine launched Centric Medical in the fall of 2014 after receiving FDA clearance for the Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in the foot & ankle.
In September 2014 Life Spine announced FDA clearance for its Long Bow expandable lateral interbody system, which it touts as the 1st interbody device on the market that expands laterally in-situ specifically for a direct lateral approach.