Clearance Summary
Signature ONE System received FDA 510(k) clearance under submission number K261510, sponsored by Orthosoft Inc. (d/b/a) Zimmer CAS. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-06-04.
- Submission: K261510
- Applicant / Sponsor: Orthosoft Inc. (d/b/a) Zimmer CAS
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2026-06-04
Classification & Regulation
This clearance is catalogued under FDA product code QHE and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.