510(k) K222056
- Device
- Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- 510(k) number
- K222056
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-26
- Date received
- 2022-07-12
- 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
- No
Applicant Contact#
- Contact
- Margaret Klippel
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3010314800
- 2242737
- 1836357
- 1828464
- 1526534
- 1818910
- 3002807314
- 3002806603
- 2528981
- 3003541440
- 3020162561
- 1721676
- 3015167917
- 3011015572
- 1720929
- 3010039400
- 1424263
- 3006128100
- 3004748528
- 9681465
- 9614209
- 3007311878
- 3004371426
- 3009973336
- 9616671
- 1833986
- 3005551626
- 3002806470
- 3036773273
- 2249615
- 2648920
- 3004635447
- 9616680
- 1220246
- 3033509898
- 1822565
- 3015259876
- 1825034
- 3020155054
- 3010155648
- 3043543260
- 3010178296
- 9610726
- 1834379
- 2011171
- 3003595343
- 3007740680
- 3016851379
- 3004513872
- 1833920
- 3000258338
- 3009732568
- 1038671
- 3007923096
- 3035366890
- 1000550978
- 3005751028
- 1220477
- 3008556682
- 1057425
- 3015516266
- 3000931034
- 2245304
- 3007200272
- 1526350
- 1047843
- 3009475821
- 1649518
- 3015542154
- 3008812251
- 1827096
- 3012392319
- 3021008900
- 1423662
- 1000200989
- 1824199
- 3010846112
- 3038503932
- 1221053
- 3010163695
Source Documents#
Other 510(k) Records For Product Code JDI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| 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 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| 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 |