MyShoulder Planner (5.3SSWPL) is an AI-enabled medical device from Medacta International S.A. that the U.S. FDA cleared through 510(k) K241292 on January 30, 2025. Its lead review panel is Orthopedic and its primary product code is KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | K241292 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Medacta International S.A. |
| Lead review panel | Orthopedic |
| Primary product code | KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Applicant (openFDA) | Medacta International S.A. |
| Applicant location | Castel San Pietro, CH |
| Device class | Class 2 |
| Regulation number | 21 CFR 888.3660 |
| Decision code | SESE |
| Submission type | Traditional |
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. MyShoulder Planner (5.3SSWPL) went through this pathway (K241292).
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 KWS covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Medacta International S.A. 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.