Exactech Receives FDA Clearance for Equinoxe Stemless Shoulder

By Julie A. Vetalice

Exactech received FDA 510(k) clearance to market the Equinoxe® Stemless Shoulder, a bone- and canal-sparing implant for total shoulder arthroplasty. Limited launch is underway, with expanded release slated for 2H18.

The device is accompanied by a single instrument tray to support O.R. efficiency, and features a 3D porous structure and bone cage to enhance biologic fixation.

The Equinoxe line, first launched in 2004, includes components for primary, revision, reverse, fracture, resurfacing, etc.

Source: Exactech

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory