FDA product code JDJ: Mesh, Surgical, Acetabular, Hip, Prosthesis
JDJ is the FDA product code for mesh, surgical, acetabular, hip, prosthesis. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 7 510(k) submissions under JDJ, from 6 different applicants. The average 510(k) review took 122 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Top JDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteonics Corp. | 2 | 1997-06-03 |
| Link America, Inc. | 1 | 1997-10-22 |
| Howmedica, Inc. | 1 | 1997-02-13 |
| Smith & Nephew Richards, Inc. | 1 | 1996-09-17 |
| Depuy, Inc. | 1 | 1996-08-01 |
1 more applicants have JDJ clearances. See the full list in Caduvo.
Most recent JDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972760 | Link America, Inc. | LINK, ACETABULAR REVISION MESH CUP | 1997-10-22 | 90 |
| K970957 | Osteonics Corp. | OSTEONICS RESTORATION ACETABULAR RING | 1997-06-03 | 78 |
| K963940 | Howmedica, Inc. | EXETER MESH | 1997-02-13 | 135 |
| K962541 | Smith & Nephew Richards, Inc. | REFLECTION ACETABULAR REINFORCEMENT RINGS | 1996-09-17 | 81 |
| K962007 | Depuy, Inc. | PROTRUSION CAGES | 1996-08-01 | 71 |
Recalls for JDJ devices
openFDA lists no recalls for product code JDJ.
Frequently asked questions
What is FDA product code JDJ?
JDJ is the FDA product code for mesh, surgical, acetabular, hip, prosthesis. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is JDJ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDJ?
Across 7 cleared submissions the average was 122 days from receipt to decision (median 90).
Which companies have the most JDJ clearances?
Osteonics Corp. (2); Link America, Inc. (1); Howmedica, Inc. (1); Smith & Nephew Richards, Inc. (1); Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JDJ
- Run a recall and safety report across every JDJ manufacturer
- Watch product code JDJ 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.