JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II
FDA product code JDI covers "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented", a Class II medical device regulated under 21 CFR 888.3350. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDI
- Device Class
- Class II
- Regulation Number
- 888.3350
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253434 | biomet | OSSTM Orthopedic Salvage System | July 1, 2026 |
| K252824 | signature orthopaedics pty | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | March 12, 2026 |
| K243571 | zimmer biomet | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L | July 31, 2025 |
| K240783 | smith and nephew | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr | October 21, 2024 |
| K241716 | howmedica osteonics corp., dba stryker orthopaedics | Global Modular Replacement System, Modular Replacement System, Modular Rotating | August 2, 2024 |
| K240418 | howmedica osteonics corp., dba stryker orthopaedics | Stryker Orthopaedics Hip Systems Labeling Update | April 12, 2024 |
| K233261 | howmedica osteonics corp. a.k.a. stryker orthopaedics | Global Modular Replacement System | December 8, 2023 |
| K222056 | howmedica osteonics corp., dba stryker orthopaedics | Global Modular Replacement System, Modular Replacement System, Modular Rotating | January 26, 2023 |
| K220216 | depuy ireland uc | C-Stem AMT LE Prosthesis | July 22, 2022 |
| K213701 | howmedica osteonics corp., dba stryker orthopaedics | Exeter® X3® RimFit® Cup | February 1, 2022 |
| K213816 | microport orthopedics | MPO Hip Instruments | January 5, 2022 |
| K210842 | zimmer | VerSys Cemented Revision/Calcar | December 10, 2021 |
| K203815 | onkos surgical | ELEOS Limb Salvage System with BioGrip | June 9, 2021 |
| K203588 | onkos surgical | ELEOS Limb Salvage System | February 5, 2021 |
| K203090 | onkos surgical | ELEOS Limb Salvage System featuring BIOGRIP | December 11, 2020 |
| K201519 | microport orthopedics | PROFEMUR® GLADIATOR® Cemented Classic Stem | December 10, 2020 |
| K193429 | howmedica osteonics | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | August 13, 2020 |
| K191449 | zimmer | ZCA All-Poly Acetabular Cups | July 16, 2020 |
| K200823 | zimmer | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | July 9, 2020 |
| K191735 | zimmer | CPT Hip System | March 20, 2020 |