Exactech Receives FDA Clearance for ExactechGPS Shoulder Application

By Julie A. Vetalice

Exactech received FDA 510(k) clearance to market the ExactechGPS® Shoulder Application, combining pre-op planning with computer-assisted surgery. Initial U.S. launch is planned for this quarter.

ExactechGPS Shoulder has been used successfully in Australia, France, Spain and the U.K. More than a pre-op planning tool alone, its intra-op capability provides visibility into the glenoid vault in real time and provides a real-time view of retroversion and inclination, reaming, drilling depth and screw placement.

First procedures for this application occurred in late 3Q16.

Sources: Exactech, Inc.; ORTHOWORLD Inc.

 

Product Labels: Shoulder Replacement, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory