Signature ONE System is an AI-enabled medical device from Orthosoft Inc. (d/b/a) Zimmer CAS that the U.S. FDA cleared through 510(k) K260104 on February 4, 2026. Its lead review panel is Orthopedic and its primary product code is QHE (Shoulder Arthroplasty Implantation System).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | K260104 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Orthosoft Inc. (d/b/a) Zimmer CAS |
| Lead review panel | Orthopedic |
| Primary product code | QHE — Shoulder Arthroplasty Implantation System |
| Applicant (openFDA) | Orthosoft Inc. (d/b/a) Zimmer CAS |
| Applicant location | Montreal, CA |
| Device class | Class 2 |
| Regulation number | 21 CFR 888.3660 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Signature ONE System went through this pathway (K260104).
openFDA lists it as a Class 2 device under 21 CFR 888.3660. Class II devices are moderate risk and are subject to general and special controls.
Product code QHE covers 4 devices on the FDA AI list. By decision date, this device is #4 of 4 under that code. Orthosoft Inc. (d/b/a) Zimmer CAS has 1 AI-enabled device on the list, and the Orthopedic panel accounts for 8 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.