FDA product code JDR: Staple, Fixation, Bone
JDR is the FDA product code for staple, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 231 510(k) submissions under JDR, 21 in the last five years, from 124 different applicants. The average 510(k) review took 133 days (median 90); 64 days on average over the last three years. FDA has posted 35 recalls for JDR devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Staple, Fixation, Bone |
| 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 JDR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 162 |
| 2018 | 8 | 100 |
| 2019 | 5 | 134 |
| 2020 | 4 | 160 |
| 2021 | 3 | 82 |
| 2022 | 5 | 174 |
| 2023 | 9 | 83 |
| 2024 | 4 | 48 |
| 2025 | 3 | 79 |
Top JDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitek Surgical Products, Inc. | 16 | 1995-05-22 |
| Acufex Microsurgical, Inc. | 9 | 1996-07-10 |
| Depuy Mitek, A Johnson & Johnson Company | 7 | 2008-05-02 |
| Biomedical Ent., Inc. | 6 | 2014-04-07 |
| Arthrex, Inc. | 5 | 2025-01-31 |
119 more applicants have JDR clearances. See the full list in Caduvo.
Most recent JDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250712 | Trax Surgical | Linkt Compression Staple System | 2025-05-14 | 65 |
| K243888 | Medline Industries, LP | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | 2025-04-11 | 114 |
| K243742 | Arthrex, Inc. | Arthrex DynaNite Nitinol Staples | 2025-01-31 | 58 |
| K243658 | Treace Medical Concepts | TMC Compression Implant System | 2024-12-26 | 29 |
| K242415 | Treace Medical Concepts | TMC Compression Implant System | 2024-09-06 | 22 |
Recalls for JDR devices
35 product recalls in 16 recall events; 11 initiated in the last five years and 6 still open. Most recent: 2022-09-27.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 5 |
| 2020 | 1 |
| 2022 | 11 |
Frequently asked questions
What is FDA product code JDR?
JDR is the FDA product code for staple, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is JDR?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDR?
Across 231 cleared submissions the average was 133 days from receipt to decision (median 90).
Which companies have the most JDR clearances?
Mitek Surgical Products, Inc. (16); Acufex Microsurgical, Inc. (9); Depuy Mitek, A Johnson & Johnson Company (7); Biomedical Ent., Inc. (6); Arthrex, Inc. (5).
Have JDR devices been recalled?
Yes: 35 product recalls across 16 recall events; the most recent began 2022-09-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JDR
- Run a recall and safety report across every JDR manufacturer
- Watch product code JDR 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.