510(k) K253630
- Device
- Mpact 3D Metal Foam
- Applicant
- Medacta International S.A.
- 510(k) number
- K253630
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-28
- Date received
- 2025-11-19
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers#
- 3020282716
- 3010057495
- 1649518
- 3017410889
- 3007913880
- 1529009
- 3004371426
- 3002807408
- 3013557690
- 3008395353
- 3006809628
- 3009173317
- 3005718816
- 3012319330
- 3008421730
- 1061927
- 3043543260
- 3004188066
- 3010132111
- 3007200272
- 1018470
- 3002806603
- 3003541440
- 1833506
- 9614209
- 2246552
- 2245304
- 1834379
- 3003061090
- 2183744
- 3030412764
- 3025603301
- 3010363503
- 1054811
- 2531477
- 3013450937
- 3009106092
- 3015398319
- 3011295718
- 3002806470
- 2528981
- 9681465
- 3012755988
- 2032521
- 3004638532
- 3007353762
- 3013014058
- 1833986
- 3002807310
- 3010120135
- 3005751028
- 3010388970
- 3005551626
- 1064858
- 3006128100
- 3022142628
- 3012425419
- 3009959868
- 3010287737
- 3011274144
- 3011189525
- 3007420745
- 3003387384
- 3009760038
- 3007923096
- 3015207155
- 3009871135
- 3005360851
- 3005852519
- 3013413393
- 3020967480
- 3001284227
- 1043653
- 3010536692
- 1721676
- 3007740680
- 8010916
- 1643264
- 3012725451
- 1000517406
Source Documents#
Other 510(k) Records For Product Code LPH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261453 | G7® Acetabular System | Zimmer Biomet | 2026-09-23 |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | 2026-06-05 |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 |