Zimmer Biomet Wins FDA Nod for Expanded Reverse Shoulder Systems

Zimmer Biomet has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a line extension to its Identity shoulder system and Comprehensive reverse shoulder systems with more implant sizes and matching surgical tools, so surgeons can treat a wider range of patient statures.

The additions to the Identity shoulder include smaller tray sizes and the corresponding instruments. It also features a new Alliance humeral bearing with Vitamin E polyethylene. The bearing was designed to work with both the Identity shoulder and Comprehensive reverse shoulder.

This way, hospitals and ambulatory surgery centers (ASCs) can use a single bearing for multiple Zimmer Biomet reverse shoulder systems to simplify supply management and reduce complexity in the OR.

The Identity shoulder is a modular shoulder replacement system that supports anatomic, reverse, and revision total shoulder arthroplasty. It’s designed to help surgeons dynamically adapt their procedure to the patient’s specific needs with a consistent set of tools and a workflow designed to promote efficiency.

The shape of the Identity stems were designed with proximal anatomic contours and a progressive, flared geometry to complement the natural humeral anatomy for an anatomic fit, so surgeons do not have to remove more bone than necessary. With the new humeral trays, the system now allows surgeons to create a true inlay shoulder by placing the implant within the bone, helping preserve bone and avoid overfilling the joint.

“We listen closely to surgeons, and what we hear consistently is that they want to treat more patients, simplify their OR and feel confident in every case,” said Brian Hatcher, president of S.E.T. & C.M.F.T. for Zimmer Biomet. “The additions to the Identity Shoulder and Comprehensive Reverse Shoulder Systems directly address all three—smaller components that extend access to more patients, a shared bearing that reduces supply complexity and a familiar workflow that surgeons can trust from day one.”