FDA Clears Expanded Zimmer Biomet ROSA Shoulder Robotic System
The new 510(k) adds robot-assisted humeral resection to glenoid reaming for both anatomic and reverse total shoulder replacement, the company said.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- The FDA cleared an updated ROSA Shoulder System under 510(k) K260582 on May 21, 2026; Zimmer Biomet announced it on May 22.
- Zimmer Biomet said the update improves robot-assisted glenoid reaming and humeral resection and supports anatomic and reverse total shoulder arthroplasty.
- The original ROSA Shoulder was cleared under K233199 in February 2024; the company cites cadaveric data for the platform's accuracy.
The US Food and Drug Administration has cleared an updated version of Zimmer Biomet's ROSA Shoulder System, a robotic platform for shoulder replacement surgery, the Warsaw, Indiana, company said in a May 22 release on its newsroom.
The FDA's 510(k) database lists the clearance as K260582, a traditional 510(k) filed by Orthosoft Inc., doing business as Zimmer CAS, of Montreal. The agency received it on February 20, 2026, and issued a substantially equivalent decision on May 21. The device is classified as an orthopedic stereotaxic instrument under product code OLO, with LLZ as a subsequent product code, and was reviewed by the orthopedic panel. The clearance letter was signed by the agency's Office of Orthopedic Devices.
What the company says changed
Zimmer Biomet said the updated 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."
The company described ROSA Shoulder as the industry's first robotic system to support both glenoid and humeral preparation for both techniques, a claim it attributed to the FDA database entry for the original system. That first version was cleared under K233199, with a file date of January 18, 2024, and a response date of February 21, 2024, according to the release.
The release said the platform's accuracy and reproducibility are supported by company data on file from cadaveric studies, and noted that "Cadaveric studies are not necessarily indicative of clinical performance."
Data platforms
The updated system uses digital tools to navigate the patient's anatomy and cross-check findings, and it connects to ZBEdge, which Zimmer Biomet calls its orthopedic intelligence platform, the company said. ROSA Shoulder will also continue to connect to the mymobility care management platform to collect data before, during and after surgery.
"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," said Brian Hatcher, Zimmer Biomet's global president for sports medicine, extremities, trauma, craniomaxillofacial and thoracic.
The release did not say when the updated system will be available to hospitals or what it will cost. The FDA had not posted a readable text version of the 510(k) summary at the time of publication; the summary pages in the agency's PDF are images.
Sources
- Zimmer Biomet Receives U.S. FDA 510(k) Clearance for Expanded Capabilities of its Robotic Shoulder System (company release), Zimmer Biomet, May 22, 2026
- 510(k) K260582: ROSA Shoulder System (database record), US Food and Drug Administration, May 21, 2026
- K260582 clearance letter, US Food and Drug Administration, May 21, 2026