Clearance Summary
ROSA® Knee System received FDA 510(k) clearance under submission number K242864, sponsored by Orthosoft Inc. (d/b/a) Zimmer CAS. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-10-18.
- Submission: K242864
- Applicant / Sponsor: Orthosoft Inc. (d/b/a) Zimmer CAS
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2024-10-18
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.