Signature™ ONE System is an AI-enabled medical device from Orthosoft Inc. (d/b/a) Zimmer CAS, listed by FDA (510(k), K260104) with a decision date of 2026-02-04. Review panel: Orthopedic.
| FDA submission number | K260104 |
|---|---|
| Pathway | 510(k) |
| Company | Orthosoft Inc. (d/b/a) Zimmer CAS |
| Review panel (specialty) | Orthopedic |
| FDA decision date | 2026-02-04 |
| Decision | Substantially Equivalent |
| Product code | QHE |
| Classification | Shoulder Arthroplasty Implantation System |
| Device class | 2 |
| Regulation number | 888.3660 |
| Review time (calendar days) | 22 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Orthopedic AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.