FDA product code JDG: Prosthesis, Hip, Femoral Component, Cemented, Metal
JDG is the FDA product code for prosthesis, hip, femoral component, cemented, metal. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel. FDA has cleared 59 510(k) submissions under JDG, 1 in the last five years, from 26 different applicants. The average 510(k) review took 101 days (median 60). FDA has posted 18 recalls for JDG devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device class | Class II |
| Regulation | 21 CFR 888.3360 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 126 |
| 2020 | 1 | 280 |
| 2022 | 1 | 187 |
Compare with all 510(k) review times · Search every JDG clearance
Top JDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 7 | 2022-02-07 |
| Howmedica Corp. | 7 | 1995-08-21 |
| Orthopedic Equipment Co., Inc. | 6 | 1977-02-17 |
| Depuy, Inc. | 5 | 1993-04-29 |
| Hexcel Medical | 4 | 1981-10-02 |
21 more applicants have JDG clearances. See the full list in Caduvo.
Most recent JDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212431 | Biomet, Inc. | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | 2022-02-07 | 187 |
| K193546 | Biomet, Inc. | Distal Centralizers | 2020-09-25 | 280 |
| K173499 | Stryker Orthopaedics | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | 2018-03-19 | 126 |
| K001984 | Stelkast Company | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT | 2000-09-27 | 90 |
| K992234 | Corin USA | THE TAPER-FIT TOTAL HIP SYSTEM | 1999-11-10 | 131 |
Recalls for JDG devices
18 product recalls in 9 recall events; 10 initiated in the last five years and 8 still open. Most recent: 2025-07-15.
| Year | Recalls |
|---|---|
| 2021 | 4 |
| 2024 | 4 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code JDG?
JDG is the FDA product code for prosthesis, hip, femoral component, cemented, metal. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel.
What device class is JDG?
Class II, regulation 21 CFR 888.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDG?
Across 59 cleared submissions the average was 101 days from receipt to decision (median 60).
Which companies have the most JDG clearances?
Biomet, Inc. (7); Howmedica Corp. (7); Orthopedic Equipment Co., Inc. (6); Depuy, Inc. (5); Hexcel Medical (4).
Have JDG devices been recalled?
Yes: 18 product recalls across 9 recall events; the most recent began 2025-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JDG
- Run a recall and safety report across every JDG manufacturer
- Watch product code JDG 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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