K241292 is an FDA 510(k) clearance for the MyShoulder Planner (5.3SSWPL). This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on January 30, 2025, 267 days after receiving the submission on May 8, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K241292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2024 |
| Decision Date | January 30, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |