FDA product code JDH: Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
JDH is the FDA product code for prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal. It is a Class III device, regulated under 21 CFR 888.3380 and reviewed by the Orthopedic panel. Devices under JDH reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for JDH devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal |
| Device class | Class III |
| Regulation | 21 CFR 888.3380 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for JDH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-12-09.
Frequently asked questions
What is FDA product code JDH?
JDH is the FDA product code for prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal. It is a Class III device, regulated under 21 CFR 888.3380 and reviewed by the Orthopedic panel.
What device class is JDH?
Class III, regulation 21 CFR 888.3380. Typical premarket route: PMA.
Have JDH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-12-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JDH
- Run a recall and safety report across every JDH manufacturer
- Watch product code JDH 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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