FDA product code JDP: Condylar Plate Fixation Implant
JDP is the FDA product code for condylar plate fixation implant. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under JDP, from 2 different applicants. The average 510(k) review took 132 days (median 132). FDA has posted 2 recalls for JDP devices.
Classification
| Field | Value |
|---|---|
| Device name | Condylar Plate Fixation Implant |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 240 |
Compare with all 510(k) review times · Search every JDP clearance
Top JDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DePuy Synthes | 1 | 2017-03-29 |
| Synthes USA | 1 | 2011-03-04 |
Most recent JDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162124 | DePuy Synthes | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins | 2017-03-29 | 240 |
| K110354 | Synthes USA | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM | 2011-03-04 | 25 |
Recalls for JDP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-02-05.
Frequently asked questions
What is FDA product code JDP?
JDP is the FDA product code for condylar plate fixation implant. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is JDP?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDP?
Across 2 cleared submissions the average was 132 days from receipt to decision (median 132).
Which companies have the most JDP clearances?
DePuy Synthes (1); Synthes USA (1).
Have JDP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JDP
- Run a recall and safety report across every JDP manufacturer
- Watch product code JDP 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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