Zimmer Biomet Receives U.S. FDA 510(k) Clearance for Expanded Capabilities of its Robotic Shoulder System

ROSA® Shoulder System is the Industry’s First Robotic System to Support Both Glenoid and Humeral Preparation for Both Anatomic and Reverse Techniques¹

(WARSAW, Ind.) May 22, 2026— Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for an advanced version of its ROSA® Shoulder System aimed at providing surgeons with informed decision-making and precision placement designed for optimal outcomes.²

The updated ROSA® Shoulder System offers improved robotically assisted glenoid reaming and humeral resection capabilities with the flexibility to support robotic total shoulder arthroplasty for anatomic and reverse techniques.

This updated system builds on evidence supporting the ROSA Shoulder platform’s accuracy and reproducibility², helping support surgical planning and intra-operative execution. It also uses digital tools to navigate the patient anatomy and cross-validate findings to reduce reliance on manual estimation, while integrating with ZBEdge®, the company’s orthopedic intelligence platform that helps surgeons use data to plan, perform and monitor care.

“The foundation of this updated technology is grounded in real-world surgeon insights,” said Brian Hatcher, global president, Sports Medicine, Extremities, Trauma, Craniomaxillofacial and Thoracic. “We partnered closely with leading shoulder surgeons, listening to their experiences in the operating room to understand exactly what they need in the moments that matter: visibility, precision, efficiency and flexibility. And, ultimately, those insights translated into an advanced shoulder system designed to support surgeon flexibility—keeping the needs of both surgeons and patients at the center of our innovations.”

In addition to using ZBEdge, ROSA Shoulder will continue to connect to mymobility® Care Management Platform to leverage pre-, intra- and post-operative data. The goal of using this data is to help surgeons move from reactive, point-in-time decisions to data-informed decisions that can lead to patient care that is more personalized and measurable.

About Zimmer Biomet
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient’s experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence.

With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation. 

For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit www.zimmerbiomet.com or follow on LinkedIn at www.linkedin.com/company/zimmerbiomet or X at www.x.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

1. U.S. Food and Drug Administration. (2024) 510(k) Premarket Notification for ROSA Shoulder (K233199). U.S. FDA Premarket Notification Database. File date of January 18, 2024, and a response date of February 21, 2024. Found here and retrieved on March 11, 2026: K233199.pd
2. Data on File FER-JSB231211-01 Rev. A. Cadaveric studies are not necessarily indicative of clinical performance.