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Home » Zimmer Biomet gets expanded FDA nod for Rosa robotic shoulder system

Zimmer Biomet gets expanded FDA nod for Rosa robotic shoulder system

May 22, 2026 By Sean Whooley

Zimmer Biomet Rosa Shoulder system
The Rosa Shoulder surgical robot system [Image courtesy of Zimmer Biomet]
Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for an advanced version of its Rosa Shoulder System.

The Rosa Shoulder system aims to provide surgeons with informed decision-making capabilities and precision placement for optimal outcomes. Rosa Shoulder initially received FDA clearance in 2024. According to Zimmer Biomet, it’s one of the only systems that can reproduce humeral head resectioning and ease the insertion of instruments into incisions. It requires no pin in the center of the glenoid during procedures.

Warsaw, Indiana-based Zimmer Biomet said its enhancements to Rosa Shoulder include improved robotically assisted glenoid reaming and humeral resection capabilities. It offers the flexibility to support robotic total shoulder arthroplasty for anatomic and reverse techniques.

The company said it built the updated system on evidence supporting Rosa Shoulder’s accuracy and reproducibility. It demonstrated its ability to support surgical planning and intraoperative execution in shoulder procedures. The system also uses digital tools to navigate the patient anatomy and cross-validate findings to reduce reliance on manual estimation.

Learn more about Zimmer Biomet’s robotic capabilities in MassDevice’s Surgical Robotics Special Report. Download the free report here.
Learn more about Zimmer Biomet’s orthopedic capabilities in MassDevice’s Orthopedic Device Companies Special Report. Download the free report here.

Zimmer Biomet also integrated its ZBEdge orthopedic intelligence platform with the updated Rosa Shoulder. ZBEdge helps surgeons use data, plan, perform and monitor care. The company designed ZBEdge to integrate its digital, robotic and implant technologies. It connects and collects objective data throughout the entire episode of care. The company aims for ZBEdge Dynamic Intelligence to transform data into insights. The goal is to elevate the standard of care.

Rosa Shoulder can also connect to the mymobility care management platform to leverage pre-, intra- and post-operative data. This helps surgeons move from reactive, point-in-time decisions to data-informed decisions.

Zimmer Biomet said these capabilities can lead to more personalized and measurable patient 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 at Zimmer Biomet. “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.”

Filed Under: 510(k), Big Data, Featured, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Robotic-Assisted, Software / IT, Surgical, Surgical Robotics 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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