FDA Clears Centric Medical’s Hammertoe Correction System

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 Hammertoe Correction System. The Hammertoe Correction System offers a dual threaded design and is inserted between the proximal and middle phalanges, so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint.
 
The current standard of care for hammertoe correction is to treat patients with wire pins (also known as “K-wires”). Many patients complain about the inconveniences that come with the wire pins, which are exposed out the end of the phalange(s) for multiple weeks. These wire pins can break and dislodge. In addition, a follow up surgery is required to remove the pins.
 
Dr. Kyle Pearson of Rezin Orthopedics and Sports Medicine in Morris, Ill., said, “Due to the advanced technology in this Hammertoe Correction System, the implant provides maintained correction through stability and compression at the PIPJ, and avoids the complications associated with K-wires.” This newest innovation allows the implant to remain within the bone, eliminating the need for the follow up surgery to remove the pin(s), and permanently correcting the pain and deformity of hammertoes.
 
The Hammertoe Correction System is designed around one of seventeen patents pending in the Centric portfolio, and represents the fifth 510(k) clearance for Centric Medical in the past twelve months. The system 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 will be released to the market in September 2016.