ROSA® Shoulder System— 510(k) K260582
Substantially EquivalentOrthosoft Inc. (d/b/a) Zimmer CAS
FDA 510(k) clearance K260582 for ROSA® Shoulder System, Substantially Equivalent on 2026-05-21. Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS. Device class: 2.
Summary
The ROSA Shoulder System comes from Orthosoft Inc., doing business as Zimmer CAS, and is filed under OLO, orthopedic stereotaxic instruments.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Orthosoft filed from Montreal, Canada. Review took 90 calendar days (February 20 to May 21, 2026).
Clearance details
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Recent devices under product code OLO
view allMore clearances from Orthosoft Inc. (d/b/a) Zimmer CAS
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.