Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System
February 14, 2017
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 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 (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.
The Metatarsal Hemi Implant has a round head and tapered stem that is fixated to the first metatarsal. The round head resurfaces the metatarsal head at the metatarsophalangeal joint. The Metatarsal Hemi Implant utilizes a cobalt chrome and highly polished “mirror” finish head that minimizes friction between articulating surfaces, reducing cartilage wear. The implant comes in 5 sizes to accommodate varying patient anatomies, and has an anti-rotational stem to increase implant stability.
The Metatarsal Hemi Implant joins a growing portfolio which includes innovative 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.
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.
Ms. Amanda Rains
Director of Marketing