JDI
- Product code
- JDI
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3350
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 565
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K253515 | 2026-08-24 | Biomet Orthopedics, Inc. | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi summary |
| K253434 | 2026-07-01 | Biomet, Inc. | OSSTM Orthopedic Salvage System summary |
| K252824 | 2026-03-12 | Signature Orthopaedics Pty, Ltd. | Evolve AP Cup, World Finned Cup, World G-Zero Liner summary |
| K243571 | 2025-07-31 | Zimmer Biomet | Trabecular Metal Acetabular Revision System, Acetabu summary |
| K240783 | 2024-10-21 | Smith & Nephew, Inc. | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; summary |
| K241716 | 2024-08-02 | Howmedica Osteonics Corp., Dba Stryker | Global Modular Replacement System, Modular Replaceme summary |
| K240418 | 2024-04-12 | Howmedica Osteonics Corp., Dba Stryker | Stryker Orthopaedics Hip Systems Labeling Update summary |
| K233261 | 2023-12-08 | Howmedica Osteonics Corp. A.K.A. Stryk | Global Modular Replacement System summary |
Official FDA classification page: JDI
Classification and pathway per current FDA publications. Data from openFDA (CC0).