FDA product code JDW: Pin, Fixation, Threaded
JDW is the FDA product code for pin, fixation, threaded. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 94 510(k) submissions under JDW, 5 in the last five years, from 59 different applicants. The average 510(k) review took 78 days (median 66); 146 days on average over the last three years. FDA has posted 100 recalls for JDW devices.
Classification
| Field | Value |
|---|---|
| Device name | Pin, Fixation, Threaded |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 63 |
| 2018 | 1 | 76 |
| 2019 | 1 | 87 |
| 2020 | 2 | 157 |
| 2021 | 2 | 80 |
| 2022 | 2 | 63 |
| 2025 | 2 | 260 |
| 2026 | 1 | 32 |
Compare with all 510(k) review times · Search every JDW clearance
Top JDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 8 | 2022-12-08 |
| Depuy, Inc. | 5 | 1999-07-14 |
| Synthes (Usa) | 4 | 2004-04-12 |
| Biomet, Inc. | 4 | 2002-05-13 |
| Buckman Co., Inc. | 4 | 1988-01-14 |
54 more applicants have JDW clearances. See the full list in Caduvo.
Most recent JDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260073 | Biodynamik, Inc. | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | 2026-02-10 | 32 |
| K250316 | Meduloc, LLC | Meduloc Intramedullary Fracture Fixation (IFF) System | 2025-10-29 | 267 |
| K241357 | Biodynamik, Inc. | XT3 System | 2025-01-22 | 253 |
| K223112 | Smith & Nephew, Inc. | MAVERICK Mini External Fixation System | 2022-12-08 | 66 |
| K213874 | Smith & Nephew, Inc. | MAVERICK External Fixation System | 2022-02-11 | 60 |
Recalls for JDW devices
100 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-09-27.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 21 |
Frequently asked questions
What is FDA product code JDW?
JDW is the FDA product code for pin, fixation, threaded. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is JDW?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDW?
Across 94 cleared submissions the average was 78 days from receipt to decision (median 66).
Which companies have the most JDW clearances?
Smith & Nephew, Inc. (8); Depuy, Inc. (5); Synthes (Usa) (4); Biomet, Inc. (4); Buckman Co., Inc. (4).
Have JDW devices been recalled?
Yes: 100 product recalls across 8 recall events; the most recent began 2018-09-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JDW
- Run a recall and safety report across every JDW manufacturer
- Watch product code JDW 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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