Mpact Double Mobility System
FDA 510(k) K143453 · Medacta International
510(k) numberK143453
Submission
- Device name
- Mpact Double Mobility System
- Applicant
- Medacta International
Castel San Pietro, CH - Received
- December 3, 2014
- Decision date
- March 2, 2015
- 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 |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| 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 |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | 06/10/2026SE |
| K160605 | MectaLIF Anterior Stand-AloneOVD · Traditional | 07/21/2016SE |
| K160289 | MasterLoc StemLZO · Traditional | 05/20/2016SE |
| K153664 | M.U.S.T. Pedicle Screw SystemNKB · Special | 01/19/2016SE |
| K151531 | MasterLoc StemLZO · Traditional | 10/30/2015SE |
| K142744 | Mecta-C TiPEEKODP · Traditional | 05/07/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K141044 | M.U.S.T. ExtensionNKB · Traditional | 08/18/2014SE |
| K140826 | GMK Sphere ExtensionJWH · Traditional | 07/15/2014SE |
Questions and answers
When was Mpact Double Mobility System cleared by the FDA?
Mpact Double Mobility System (K143453) received a 510(k) decision of Substantially Equivalent on March 2, 2015, 89 days after the submission was received.
What is the product code of K143453?
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.