Zimmer Biomet Earns 510(k) for Updated ROSA Shoulder System

Zimmer Biomet was granted FDA 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.

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 reproducibility, 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 orthopedic intelligence platform that helps surgeons use data to plan, perform and monitor care.

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.

Source: Zimmer Biomet

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