FDA product code JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
JDI is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, cemented. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel. FDA has cleared 565 510(k) submissions under JDI, 12 in the last five years, from 116 different applicants. The average 510(k) review took 125 days (median 87); 204 days on average over the last three years. FDA has posted 255 recalls for JDI devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3350 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 282 |
| 2018 | 1 | 168 |
| 2019 | 2 | 179 |
| 2020 | 7 | 218 |
| 2021 | 3 | 161 |
| 2022 | 3 | 92 |
| 2023 | 2 | 134 |
| 2024 | 3 | 107 |
| 2025 | 1 | 255 |
| 2026 | 3 | 250 |
Compare with all 510(k) review times · Search every JDI clearance
Top JDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 51 | 2026-07-01 |
| Depuy, Inc. | 45 | 1998-05-20 |
| Howmedica Corp. | 35 | 1998-12-16 |
| Osteonics Corp. | 29 | 1998-12-04 |
| Zimmer, Inc. | 27 | 2021-12-10 |
111 more applicants have JDI clearances. See the full list in Caduvo.
Most recent JDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253515 | Biomet Orthopedics, Inc. | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | 2026-08-24 | 290 |
| K253434 | Biomet, Inc. | OSSTM Orthopedic Salvage System | 2026-07-01 | 273 |
| K252824 | Signature Orthopaedics Pty, Ltd. | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | 2026-03-12 | 188 |
| K243571 | Zimmer Biomet | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | 2025-07-31 | 255 |
| K240783 | Smith & Nephew, Inc. | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | 2024-10-21 | 214 |
Recalls for JDI devices
255 product recalls in 76 recall events; 17 initiated in the last five years and 15 still open. Most recent: 2025-09-09.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 12 |
| 2019 | 7 |
| 2020 | 78 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code JDI?
JDI is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, cemented. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel.
What device class is JDI?
Class II, regulation 21 CFR 888.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDI?
Across 565 cleared submissions the average was 125 days from receipt to decision (median 87).
Which companies have the most JDI clearances?
Biomet, Inc. (51); Depuy, Inc. (45); Howmedica Corp. (35); Osteonics Corp. (29); Zimmer, Inc. (27).
Have JDI devices been recalled?
Yes: 255 product recalls across 76 recall events; the most recent began 2025-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JDI
- Run a recall and safety report across every JDI manufacturer
- Watch product code JDI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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