Zimmer Biomet Gains FDA Clearance for Sidus Stem-free Shoulder

By Julie A. Vetalice

Zimmer Biomet received FDA 510(k) clearance for the Sidus® Stem-Free total shoulder. The device will launch within 1Q18.

Sidus was launched on the European market in 2012. U.S. launch of the stemless shoulder was alluded to in ZBH's 3Q17 revenue reporting, alongside an augmented baseplate, also expected for 2018 launch. Sidus presents competition in the U.S. for Wright Medical's stemless shoulder, Simpliciti, which received U.S. market clearance in 2015 ahead of the Wright/Tornier merger.

Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.

 

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory