510(k) K253434
- Device
- OSSTM Orthopedic Salvage System
- Applicant
- Biomet, Inc.
- 510(k) number
- K253434
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-01
- Date received
- 2025-10-01
- 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
Applicant Contact#
- Contact
- Yoriko Kobayashi
- Address
- 56 E Bell Dr. Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3020967480
- 3013450937
- 1833506
- 1836357
- 1000200989
- 1226544
- 3027484613
- 1038671
- 3009871135
- 3013302242
- 1828464
- 1220477
- 3015167917
- 3010132111
- 1030489
- 3010163695
- 3015516266
- 3009882462
- 3006801265
- 3010386387
- 3004513872
- 3011274144
- 3015259876
- 3003639920
- 9616680
- 2531477
- 2249697
- 3009475821
- 3000196378
- 2648920
- 2242737
- 1818910
- 3010288357
- 3002807314
- 3005180920
- 1225675
- 3010039400
- 3002808022
- 9610612
- 3009241418
- 3008395353
- 3013055499
- 2246552
- 3016438694
- 3018052045
- 3005581234
- 1531174
- 1529009
- 1018470
- 3005751028
- 3008281151
- 3012523063
- 3020282716
- 3004153896
- 3005718816
- 3004371426
- 9613350
- 2245304
- 3009973336
- 3009732568
- 2528981
- 3015542154
- 3010287737
- 3010120135
- 3011015572
- 3020155054
- 1221763
- 3022142628
- 3010065126
- 3017397663
- 3008110533
- 9616944
- 1833986
- 3013014058
- 1645151
- 1825034
- 3004142400
- 3011170410
- 1827096
- 3008868758
Source Documents#
Other 510(k) Records For Product Code JDI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 |
| 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 |
| 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 |