K241461 is an FDA 510(k) clearance for the Mpact Constrained Liner. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II - Special Controls, product code KWZ).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 31, 2025, 434 days after receiving the submission on May 23, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310.
| 510(k) Number | K241461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2024 |
| Decision Date | July 31, 2025 |
| Days to Decision | 434 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3310 |