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Home » Zimmer Biomet wins expanded FDA nod for shoulder systems

Zimmer Biomet wins expanded FDA nod for shoulder systems

April 16, 2026 By Sean Whooley

Zimmer Biomet Identity Shoulder System and Comprehensive Reverse Shoulder Systems
[Image courtesy of Zimmer Biomet]
Zimmer Biomet (NYSE:ZBH) announced that it received FDA 510(k) clearance for a line extension to its existing Identity and Comprehensive shoulder systems.

The clearance expands the existing capabilities for the Identity shoulder system and Comprehensive reverse shoulder systems with additional implant sizes and matching surgical tools. It aims to enable surgeons to treat a wider range of patient statures.

Identity, a modular shoulder replacement system, supports anatomic, reverse and revision total shoulder arthroplasty. The company designed it to enable surgeons to dynamically adapt their procedure to the specific needs of the patient. Identity stems feature proximal anatomic contours and a progressive, flared geometry to complement the natural humeral anatomy.

The system also has a proven porous plasma spray (PPS) coating for biological fixation. With new humeral trays, surgeons can create a true inlay shoulder by placing the implant within the bone. This helps preserve bone and avoid overfilling the joint, the company says. Additionally, the system comes in a broad range of implant sizes and configurations.

Identity initially won FDA clearance in 2022. In 2024, the FDA cleared the company’s Rosa surgical robot for shoulder surgeries with Identity.

Warsaw, Indiana-based Zimmer Biomet said the additions to Identity include smaller tray sizes and corresponding instruments. Additionally, clearance covers a new Alliance humeral bearing with Vitamin E polyethylene. Zimmer Biomet says this material has been shown to have low wear and resist oxidation.

The bearing also works with the Comprehensive reverse shoulder systems to simplify supply management and reduce OR complexity.

“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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedic Implants, Orthopedics, Regulatory/Compliance Tagged With: FDA, Zimmer Biomet

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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