FDA OKs marketing of Centric Medical implant system
HUNTLEY - The U.S. Food and Drug Administration (FDA) has given Centric Medical 510(k) marketing clearance to the Metatarsal Hemi Implant System.
The Metatarsal Hemi Implant for the metatarsophalangeal joint is intended for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal joint.
The device is a single use implant intended to be used with bone cement or without bone cement.
The Metatarsal Hemi Implant joins Cenrtic Medical's portfolio, which includes osteobiologic products, as well as the groundbreaking TARSA-LINK Stand-Alone Wedge Fixation System, the market's first stand-alone osteotomy wedge with built-in fixation. The system was released to the market in September 2016.
Centric Medical is a division of Life Spine, Inc.