FDA product code JDS: Nail, Fixation, Bone
JDS is the FDA product code for nail, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 53 510(k) submissions under JDS, 5 in the last five years, from 26 different applicants. The average 510(k) review took 96 days (median 75); 178 days on average over the last three years. FDA has posted 21 recalls for JDS devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nail, 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 JDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 3 | 163 |
| 2023 | 1 | 86 |
| 2024 | 3 | 154 |
| 2025 | 1 | 202 |
Compare with all 510(k) review times · Search every JDS clearance
Top JDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 12 | 2025-06-12 |
| Synthes (Usa) | 11 | 2011-12-05 |
| Howmedica Corp. | 4 | 1994-09-12 |
| Biomet, Inc. | 3 | 2020-02-20 |
| Disco-O-Tech Medical Technologies, Ltd. | 2 | 2000-12-28 |
21 more applicants have JDS clearances. See the full list in Caduvo.
Most recent JDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243608 | Smith & Nephew, Inc. | TRIGEN Stable Lock Nut & Washer | 2025-06-12 | 202 |
| K240061 | Smith & Nephew, Inc. | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | 2024-09-20 | 255 |
| K241804 | Smith & Nephew, Inc. | TRIGEN INTERTAN 10S Nail System | 2024-08-22 | 62 |
| K233150 | Narang Medical , Ltd. | NET BRAND Osteosynthesis Nailing System | 2024-02-20 | 146 |
| K230761 | Smith & Nephew, Inc. | TRIGEN META-NAIL Nail System | 2023-06-14 | 86 |
Recalls for JDS devices
21 product recalls in 15 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 2 |
| 2022 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code JDS?
JDS is the FDA product code for nail, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is JDS?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDS?
Across 53 cleared submissions the average was 96 days from receipt to decision (median 75).
Which companies have the most JDS clearances?
Smith & Nephew, Inc. (12); Synthes (Usa) (11); Howmedica Corp. (4); Biomet, Inc. (3); Disco-O-Tech Medical Technologies, Ltd. (2).
Have JDS devices been recalled?
Yes: 21 product recalls across 15 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code JDS
- Run a recall and safety report across every JDS manufacturer
- Watch product code JDS 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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