Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k) K251043 · Medacta International S.A.
510(k) numberK251043
Submission
- Device name
- Mpact 3D Metal Implants Extension DMLS Technology
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- April 3, 2025
- Decision date
- January 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | Lima Corporate S.P.A. | 08/29/2025SE |
More from Lima Corporate S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | 08/28/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | 05/05/2026SE |
| K253940 | M.U.S.T. Pedicle Screw System - ExtensionNKB · Traditional | 04/28/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | 02/26/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | 02/03/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | 01/09/2026SE |
| K242603 | MyPAO SA guidesPBF · Traditional | 11/19/2025SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | 10/31/2025SE |
| K250450 | Coated hip implantsLZO · Traditional | 09/19/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | 09/12/2025SE |
Questions and answers
When was Mpact 3D Metal Implants Extension DMLS Technology cleared by the FDA?
Mpact 3D Metal Implants Extension DMLS Technology (K251043) received a 510(k) decision of Substantially Equivalent on January 28, 2026, 300 days after the submission was received.
What is the product code of K251043?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.