510(k) K253515
- Device
- Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
- Applicant
- Biomet Orthopedics, Inc.
- 510(k) number
- K253515
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-24
- Date received
- 2025-11-07
- 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
- Ainsley Carne
- Address
- 56 E. Bell Dr. Warsaw IN US 46582 46582
FDA Registration Numbers#
- 3010065126
- 1000200989
- 3002808022
- 3018052045
- 3009241418
- 3009173317
- 3010041693
- 3009546990
- 1000550978
- 3012319330
- 1057425
- 3015398319
- 3008281151
- 3006946279
- 3015542154
- 3006085220
- 3013176080
- 3015167917
- 1030489
- 9681642
- 3036756245
- 3004142400
- 3017397663
- 9616680
- 1827096
- 1226544
- 9613369
- 2245304
- 1220246
- 3010363503
- 1835251
- 1834331
- 1834379
- 3043543260
- 1220477
- 1221053
- 3006395932
- 3026771806
- 2528981
- 2648920
- 9616671
- 1058584
- 3012392319
- 3000931034
- 3010536692
- 3012130008
- 3010386387
- 3004513872
- 3011170410
- 3001278222
- 1020279
- 3010039400
- 3006809628
- 3007913880
- 3006017180
- 3005718816
- 3008262872
- 3010057495
- 1000547811
- 3010288357
- 2134285
- 3009888740
- 3004748528
- 3011683674
- 3010287737
- 3009882462
- 3011274144
- 3009959868
- 3008102042
- 3009973336
- 2244478
- 3009106092
- 1645151
- 3004371426
- 3004641308
- 3002907620
- 3008556682
- 3009475821
- 3009732568
- 3010468876
Source Documents#
Other 510(k) Records For Product Code JDI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 |
| 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 |