Mpact Constrained Liner
FDA 510(k) K241461 · Medacta International S.A.
510(k) numberK241461
Submission
- Device name
- Mpact Constrained Liner
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- May 23, 2024
- Decision date
- July 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3310
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240639 | PINNACLETM Constrained Acetabular LinersKWZ · Special | Depuy Ireland UC | 04/04/2024SE |
| K162641 | Smith & Nephew, Inc. R3 Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 06/19/2017SE |
| K163497 | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal…KWZ · Traditional | Encore Medical L.P. | 03/02/2017SE |
| K161610 | EXPRT Revision Hip SystemKWZ · Traditional | Encore Medical L.P. | 11/09/2016SE |
| K122139 | Smith & Nephew R3 Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 10/16/2012SE |
| K111635 | Smith & Nephew RJ Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 09/09/2011SE |
| K101730 | Longevity It Highly Crosslinked Polyethylene Constrained LinersKWZ · Traditional | Zimmer, Inc. | 12/03/2010SE |
| K083566 | R3 Constrained Liner, Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 03/03/2009SE |
| K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerKWZ · Traditional | Zimmer, Inc. | 01/07/2008SE |
| K071059 | Depuy SPA Porous Coated Proximal SleeveKWZ · Traditional | DePuy Orthopaedics, Inc. | 11/09/2007SE |
More from DePuy Orthopaedics, Inc.
| 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 |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
| 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 |
Questions and answers
When was Mpact Constrained Liner cleared by the FDA?
Mpact Constrained Liner (K241461) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 434 days after the submission was received.
What is the product code of K241461?
The FDA product code is KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3310.