FDA product code JDB: Prosthesis, Elbow, Semi-Constrained, Cemented
JDB is the FDA product code for prosthesis, elbow, semi-constrained, cemented. It is a Class II device, regulated under 21 CFR 888.3160 and reviewed by the Orthopedic panel. FDA has cleared 27 510(k) submissions under JDB, 1 in the last five years, from 12 different applicants. The average 510(k) review took 96 days (median 90). FDA has posted 26 recalls for JDB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3160 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 149 |
| 2018 | 1 | 108 |
| 2020 | 1 | 254 |
| 2022 | 1 | 40 |
Compare with all 510(k) review times · Search every JDB clearance
Top JDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tornier | 5 | 2007-08-24 |
| Tornier, Inc. | 4 | 2020-08-05 |
| Small Bone Innovations, Inc. | 3 | 2010-12-20 |
| Depuy, Inc. | 3 | 1983-01-20 |
| Johnson & Johnson Professionals, Inc. | 2 | 1998-11-06 |
7 more applicants have JDB clearances. See the full list in Caduvo.
Most recent JDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222807 | Lima Corporate S.P.A. | TEMA Elbow system - Line extension | 2022-10-26 | 40 |
| K193247 | Tornier, Inc. | LATITUDE EV Total Elbow Arthroplasty | 2020-08-05 | 254 |
| K182461 | Tornier, Inc. | LATITUDE EV Total Elbow Arthroplasty | 2018-12-27 | 108 |
| K171010 | Tornier, Inc. | Latitude EV Total Elbow Arthroplasty | 2017-08-31 | 149 |
| K102180 | Small Bone Innovations, Inc. | RHEAD RADIAL HEAD EXTENDED STEMS | 2010-12-20 | 140 |
Recalls for JDB devices
26 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-03-03.
| Year | Recalls |
|---|---|
| 2017 | 18 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JDB?
JDB is the FDA product code for prosthesis, elbow, semi-constrained, cemented. It is a Class II device, regulated under 21 CFR 888.3160 and reviewed by the Orthopedic panel.
What device class is JDB?
Class II, regulation 21 CFR 888.3160. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDB?
Across 27 cleared submissions the average was 96 days from receipt to decision (median 90).
Which companies have the most JDB clearances?
Tornier (5); Tornier, Inc. (4); Small Bone Innovations, Inc. (3); Depuy, Inc. (3); Johnson & Johnson Professionals, Inc. (2).
Have JDB devices been recalled?
Yes: 26 product recalls across 6 recall events; the most recent began 2025-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JDB
- Run a recall and safety report across every JDB manufacturer
- Watch product code JDB 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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