510(k) K243571
- Device
- Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- Applicant
- Zimmer Biomet
- 510(k) number
- K243571
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-31
- Date received
- 2024-11-18
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Sean Gleason
- Address
- 1800 W. Center St. Warsaw IN US 46580 46580
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3002807090
- 3027484613
- 1833506
- 2242737
- 3004641308
- 3005180920
- 3000236920
- 2133928
- 3007913880
- 1000547811
- 3009241418
- 1649390
- 3006085220
- 3013176080
- 3002807315
- 3017410889
- 3021008900
- 3010386387
- 3010057495
- 3006801265
- 3014252644
- 3009871135
- 8044172
- 1644408
- 3023852420
- 1834331
- 3003541440
- 1824199
- 1018470
- 3010287737
- 3005323511
- 1833920
- 1827096
- 3006809628
- 3020162561
- 3009760038
- 3025603301
- 3003595343
- 3005061536
- 3010163695
- 3004142400
- 1643264
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3009106092
- 3014763043
- 2648920
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3005581234
- 3009475821
- 3010041693
- 3006395932
- 3004635447
- 3004180226
- 3002807314
- 3004153896
- 3009756327
- 3013302242
- 3007923096
- 3010041993
- 3015259876
- 3013014058
- 3010039400
- 3010132111
- 9613350
- 3000258338
- 3010846112
- 2249697
- 3012392319
- 3012523063
- 3007189546
- 3010288357
- 3016438694
- 3020967480
- 3009973336
- 3008110533
- 3010097171
- 3006128100
- 3018052045
- 3002907620
- 3015398319
- 3002808022
- 3038503932
- 1649518
- 9681465
- 1058584
- 3001278222
- 1030489
- 3015167917
- 3011015572
- 3030412764
- 3007200272
- 3005562917
- 9681642
- 1057425
- 1645151
- 3002807310
- 1000550978
- 3012329926
- 3010120135
- 3020282716
- 3011170410
- 3007311878
- 3009882462
- 3009732568
- 3014644608
- 3020155054
- 3005751028
- 1526534
- 3002807295
- 1828288
- 3005360851
- 1828464
- 1038671
- 1835251
- 3009888740
- 1825034
- 3009173317
- 2245304
- 9616680
- 3013450937
- 1834379
- 1221053
- 3008102042
- 1220246
- 2030624
- 1720929
- 3043543260
- 3004371426
- 3013086329
- 3007366790
- 8010916
- 3036773273
- 8010379
- 3009973505
- 3010314800
- 3015207155
- 1526350
- 3010536692
- 3017397663
- 1221763
- 1220477
- 1047843
- 3006017180
- 1531174
- 3008021110
- 1643817
- 3000196378
- 9610726
- 3019807891
- 1226544
- 3009998573
- 3006356043
- 3022142628
- 3003639920
- 3002806470
- 3008868758
- 3010220595
- 3010178296
- 1833986
- 3003387384
- 9614209
- 3008572101
- 3005718816
- 3035366890
- 3033509898
- 3010173425
- 1722511
- 3036756245
- 3008556682
- 3012130008
- 9616944
- 3004513872
- 3011277306
- 2244478
- 1822565
- 3012725451
- 3004748528
- 1818910
- 2134285
- 3010468876
- 3013055499
- 3008812251
- 3002806603
- 3011295718
- 3008744062
- 1020279
- 3010155648
- 3011274144
- 3012319330
- 3010065126
- 2249615
- 3042508254
- 3009546990
- 2531477
- 3000931034
- 8043792
- 3008281151
- 2011171
- 3008395353
- 3003761012
- 3010363503
- 1836357
- 3016851379
- 1424263
- 2528981
- 3003998208
- 3018094310
- 9616671
- 3009959868
- 9613369
- 3005551626
- 1529009
- 3014302784
- 3008262872
Source Documents
Other 510(k) Records For Product Code JDI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 |
| K203588 | ELEOS Limb Salvage System | Onkos Surgical | 2021-02-05 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020-12-10 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020-08-13 |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | 2020-07-16 |