510(k) K241461
- Device
- Mpact Constrained Liner
- Applicant
- Medacta International S.A.
- 510(k) number
- K241461
- Product code
- KWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-31
- Date received
- 2024-05-23
- Regulation
- 888.3310
- Classification name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers#
- 9616680
- 1000577893
- 3006128100
- 8010379
- 3007200272
- 2528981
- 3022142628
- 3014763043
- 1423662
- 3021008900
- 3007740680
- 3002807314
- 3010537287
- 3010287737
- 3005323511
- 3033509898
- 3008110533
- 3008668801
- 2648920
- 3002907620
- 3010206549
- 3000196378
- 3026771806
- 3009973505
- 1043653
- 1221053
- 2249697
- 3008868758
- 1644408
- 3006395932
- 2245304
- 1018470
- 3008262872
- 3008556682
- 8043792
- 1818910
- 1836357
- 3000264985
- 3009475821
- 3005913274
- 3020282716
- 1220477
- 3010220595
- 3005061536
- 3009888740
- 3010041693
- 3003998208
- 3008021110
- 9616944
- 3005180920
- 3005551626
- 1020279
- 1825034
- 3003639920
- 3002806470
- 3001278222
- 3009241418
- 3011277306
- 1649518
- 1833986
- 3030338875
- 3013055499
- 1828288
- 1822565
- 3016438694
- 3023852420
- 2531477
- 3002806535
- 1526534
- 3006809628
- 3025603301
- 9613350
- 1219655
- 3002807315
- 3009546990
- 3012392319
- 3012319330
- 8044172
- 3015207155
Source Documents#
Other 510(k) Records For Product Code KWZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | 2024-04-04 |
| K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017-06-19 |
| K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | Encore Medical L.P. | 2017-03-02 |
| K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016-11-09 |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | 2012-10-16 |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011-09-09 |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | 2010-12-03 |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | 2009-03-03 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | 2007-11-09 |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | 2007-07-19 |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | 2007-07-13 |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2007-05-18 |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |