K251043 is an FDA 510(k) clearance for the Mpact 3D Metal Implants Extension – DMLS Technology. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on January 28, 2026, 300 days after receiving the submission on April 3, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K251043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |