MyShoulder Planner (5.3SSWPL) is an AI-enabled medical device from Medacta International S.A., listed by FDA (510(k), K241292) with a decision date of 2025-01-30. Review panel: Orthopedic.
| FDA submission number | K241292 |
|---|---|
| Pathway | 510(k) |
| Company | Medacta International S.A. |
| Review panel (specialty) | Orthopedic |
| FDA decision date | 2025-01-30 |
| Decision | Substantially Equivalent |
| Product code | KWS |
| Classification | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | 2 |
| Regulation number | 888.3660 |
| Review time (calendar days) | 267 |
| Applicant country | CH |
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.