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#
- 3007189546
- 9616671
- 2249615
- 3012392319
- 1835251
- 3013176080
- 3017410889
- 3007311878
- 3042508254
- 3020282716
- 1000547811
- 3010097171
- 3020155054
- 1834331
- 3010220595
- 3014252644
- 3026771806
- 3002806470
- 3005751028
- 3009475821
- 3010057495
- 3005323511
- 3010468876
- 3017397663
- 3010386387
- 3012523063
- 3015516266
- 3004635447
- 3004748528
- 3005061536
- 1030489
- 3009241418
- 3016851379
- 9616680
- 1833920
- 1643817
- 3008110533
- 1038671
- 3000931034
- 3003639920
- 3013086329
- 1450662
- 3009760038
- 3006128100
- 1833986
- 3004153896
- 3009998573
- 2133928
- 3016438694
- 1722511
- 3002808022
- 1825034
- 3008395353
- 3003387384
- 9614209
- 3013450937
- 9610726
- 3004641308
- 3010314800
- 9681465
- 3020967480
- 1828464
- 3006809628
- 3012319330
- 3010287737
- 3011277306
- 3015207155
- 3043543260
- 9610612
- 3008812251
- 3015167917
- 3020162561
- 1424263
- 3035366890
- 3005562917
- 3014302784
- 1643264
- 3008021110
- 3009959868
- 3005581234
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 |