510(k) K233261
- Device
- Global Modular Replacement System
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- 510(k) number
- K233261
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-08
- Date received
- 2023-09-29
- 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
- Denise Daugert
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
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
Source Documents
Other 510(k) Records For Product Code JDI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 |
| 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 |
| 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 |