Extremity Medical Receives FDA 510(k) Clearance for Align Ankle Fusion System

By Julie A. Vetalice

Extremity Medical received FDA 510(k) clearance to market the Align Ankle Fusion System™. Initial launch is slated for mid-April 2016.

The plating system is intended to facilitate arthrodesis of the ankle, including tibiotalocalcaneal and tibiotalar joints.

Source: Extremity Medical, Inc.

Extremity Medical focuses on fixation and arthroplasty systems for the lower and distal upper extremities.

Thus far in 2016, the company has launched IO FIX 2.0™ implants and instruments for midfoot fusion indications. Review products launched since 2011 with these results from the ORTHOWORLD site search function.

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory