Centric Medical Receives FDA Clearance for Hammertoe Correction System

By Julie A. Vetalice

Centric Medical received FDA 510(k) clearance to market the Hammertoe Correction System. Market launch will occur at the end of 3Q16.

The system is inserted between the proximal and middle phalanges, with opposing threads fixating on the phalangeal canal of the toe to compress the joint. Whereas k-wires, the current standard of care for this application, are subject to breakage and require a second surgery for removal, Centric's implant remains within the bone, maintaining correction through stability and compression.

Centric Medical's TARSA-LINK StandAlone Wedge PEEK fixation system for foot/ankle launched in early 2Q16, and its Subtalar Arthroereisis Implant received 510(k) clearance in late 2Q.

Sources: Centric Medical, ORTHOWORLD Inc.

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory