Zimmer Biomet Wins FDA Nod for Updated Rosa Robotic Shoulder System

Zimmer Biomet has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an advanced version of its Rosa shoulder system. The new capability seeks to provide surgeons with informed decision-making and precision placement designed for optimal outcomes.

The updated Rosa shoulder system features robotically-assisted glenoid reaming and humeral resection capabilities. It has the flexibility to support robotic total shoulder arthroplasty for anatomic and reverse techniques.

The company said the updated system builds on evidence supporting Rosa Shoulder’s accuracy and reproducibility by helping support surgical planning and intra-operative execution. It uses digital tools to navigate patient anatomy and cross-validate findings to reduce reliance on manual integration.

It integrates 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.”

Rosa Shoulder will continue to connect to the mymobility care management platform to leverage pre-, intra-, and post-op data. Zimmer Biomet said the goal of using this data is helping surgeons move from reactive, point-in-time decisions to data-informed decisions that can lead to more personalized, measurable patient care.