FDA product code JDC: Prosthesis, Elbow, Constrained, Cemented
JDC is the FDA product code for prosthesis, elbow, constrained, cemented. It is a Class II device, regulated under 21 CFR 888.3150 and reviewed by the Orthopedic panel. FDA has cleared 29 510(k) submissions under JDC, from 12 different applicants. The average 510(k) review took 105 days (median 85). FDA has posted 21 recalls for JDC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3150 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 262 |
Compare with all 510(k) review times · Search every JDC clearance
Top JDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 8 | 2019-01-28 |
| Biomet, Inc. | 7 | 2005-09-06 |
| Biomet Manufacturing Corp | 2 | 2016-02-03 |
| DePuy Orthopaedics, Inc. | 2 | 2006-04-14 |
| Depuy, Inc. | 2 | 2004-12-08 |
7 more applicants have JDC clearances. See the full list in Caduvo.
Most recent JDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181362 | Lima Corporate S.P.A. | TEMA Elbow System | 2019-02-16 | 269 |
| K181307 | Zimmer, Inc. | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | 2019-01-28 | 256 |
| K153398 | Biomet Manufacturing Corp | Comprehensive SRS/Nexel Elbow | 2016-02-03 | 71 |
| K150501 | Zimmer, Inc. | Zimmer Nexel Total Elbow Ulnar Cement Diverter | 2015-04-23 | 56 |
| K123862 | Zimmer, Inc. | ZIMMER NEXEL TOTAL ELBOW | 2013-03-12 | 88 |
Recalls for JDC devices
21 product recalls in 13 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JDC?
JDC is the FDA product code for prosthesis, elbow, constrained, cemented. It is a Class II device, regulated under 21 CFR 888.3150 and reviewed by the Orthopedic panel.
What device class is JDC?
Class II, regulation 21 CFR 888.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDC?
Across 29 cleared submissions the average was 105 days from receipt to decision (median 85).
Which companies have the most JDC clearances?
Zimmer, Inc. (8); Biomet, Inc. (7); Biomet Manufacturing Corp (2); DePuy Orthopaedics, Inc. (2); Depuy, Inc. (2).
Have JDC devices been recalled?
Yes: 21 product recalls across 13 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JDC
- Run a recall and safety report across every JDC manufacturer
- Watch product code JDC 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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