510(k) K121055
- Device
- METS MODULAR TOTAL FEMUR
- Applicant
- STANMORE IMPLANTS WORLDWIDE LTD.
- 510(k) number
- K121055
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-19
- Date received
- 2012-04-06
- 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
- NANCY C MACDONALD
- Address
- 690 Canton St., Suite 302 Canton MA US 02090 02090
FDA Registration Numbers#
- 1000550978
- 9616680
- 3020967480
- 3006128100
- 8010379
- 3000258338
- 3007200272
- 2528981
- 3022142628
- 9610612
- 3014763043
- 2244478
- 1526350
- 1423662
- 3021008900
- 3015167917
- 3007740680
- 3010846112
- 3002807314
- 3016851379
- 3010287737
- 3005323511
- 3033509898
- 3008110533
- 3010041993
- 3009760038
- 3007189546
- 3005562917
- 2648920
- 1047843
- 3015398319
- 3002907620
- 3018094310
- 2011171
- 3000196378
- 3009973505
- 3026771806
- 1043653
- 3004371426
- 1221053
- 2249697
- 3008868758
- 1644408
- 3006395932
- 2245304
- 3017410889
- 3018052045
- 3002807090
- 3010097171
- 1018470
- 3008262872
- 3009756327
- 3010363503
- 3008556682
- 1824199
- 9616671
- 8043792
- 1057425
- 1818910
- 1000547811
- 1836357
- 3009475821
- 3020282716
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3003761012
- 3010041693
- 3003998208
- 3008021110
- 9616944
- 3005180920
- 3005551626
- 1020279
- 3003541440
- 3011015572
- 1825034
- 3003639920
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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