FDA product code JDL: Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
JDL is the FDA product code for prosthesis, hip, semi-constrained (metal cemented acetabular component). It is a Class III device, regulated under 21 CFR 888.3320 and reviewed by the Orthopedic panel. FDA has cleared 45 510(k) submissions under JDL, from 25 different applicants. The average 510(k) review took 153 days (median 92). FDA has posted 5 recalls for JDL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Device class | Class III |
| Regulation | 21 CFR 888.3320 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every JDL clearance
Top JDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 7 | 2007-07-11 |
| Howmedica Corp. | 5 | 1994-02-22 |
| Osteonics Corp. | 3 | 1994-09-20 |
| Kirschner Medical Corp. | 3 | 1987-05-08 |
| Biomet, Inc. | 2 | 2004-12-21 |
20 more applicants have JDL clearances. See the full list in Caduvo.
Most recent JDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073499 | Zimmer, Inc. | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | 2008-08-07 | 238 |
| K070785 | Wrightmedicaltechnologyinc | DYNASTY ACETABULAR SYSTEM | 2007-07-11 | 112 |
| K061844 | Wrightmedicaltechnologyinc | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | 2006-12-06 | 160 |
| K051995 | Wrightmedicaltechnologyinc | PROFEMUR RENAISSANCE HIP STEM | 2005-08-22 | 28 |
| K051348 | Wrightmedicaltechnologyinc | CONSERVE TOTAL FEMORAL HEAD | 2005-08-19 | 87 |
Recalls for JDL devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code JDL?
JDL is the FDA product code for prosthesis, hip, semi-constrained (metal cemented acetabular component). It is a Class III device, regulated under 21 CFR 888.3320 and reviewed by the Orthopedic panel.
What device class is JDL?
Class III, regulation 21 CFR 888.3320. Typical premarket route: PMA.
How long does a 510(k) take for product code JDL?
Across 45 cleared submissions the average was 153 days from receipt to decision (median 92).
Which companies have the most JDL clearances?
Wrightmedicaltechnologyinc (7); Howmedica Corp. (5); Osteonics Corp. (3); Kirschner Medical Corp. (3); Biomet, Inc. (2).
Have JDL devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JDL
- Run a recall and safety report across every JDL manufacturer
- Watch product code JDL 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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