FDA product code JDQ: Cerclage, Fixation
JDQ is the FDA product code for cerclage, fixation. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel. FDA has cleared 130 510(k) submissions under JDQ, 11 in the last five years, from 75 different applicants. The average 510(k) review took 131 days (median 90); 140 days on average over the last three years. FDA has posted 15 recalls for JDQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cerclage, Fixation |
| Device class | Class II |
| Regulation | 21 CFR 888.3010 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 295 |
| 2018 | 6 | 142 |
| 2020 | 4 | 104 |
| 2022 | 2 | 179 |
| 2023 | 3 | 242 |
| 2024 | 3 | 153 |
| 2025 | 2 | 178 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every JDQ clearance
Top JDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pioneer Surgical Technology | 11 | 2000-10-06 |
| Synthes (Usa) | 8 | 2011-07-28 |
| Howmedica Corp. | 8 | 1997-07-16 |
| A & E Medical Corporation | 4 | 2020-03-23 |
| Arthrex, Inc. | 3 | 2025-02-20 |
70 more applicants have JDQ clearances. See the full list in Caduvo.
Most recent JDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261271 | Pioneer Surgical Technology, Inc. | Cable-Ready® Cable Grip System | 2026-07-16 | 90 |
| K243905 | GM Dos Reis Industria e Comercio Ltda. | Stitch Cerclage Suture Tapes | 2025-08-14 | 238 |
| K243344 | Arthrex, Inc. | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | 2025-02-20 | 118 |
| K232733 | Medacta International S.A. | Mbrace Cable | 2024-05-03 | 239 |
| K233949 | Smith & Nephew, Inc. | ACCORD Cable System | 2024-03-13 | 90 |
Recalls for JDQ devices
15 product recalls in 10 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-10.
| Year | Recalls |
|---|---|
| 2019 | 5 |
Frequently asked questions
What is FDA product code JDQ?
JDQ is the FDA product code for cerclage, fixation. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel.
What device class is JDQ?
Class II, regulation 21 CFR 888.3010. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDQ?
Across 130 cleared submissions the average was 131 days from receipt to decision (median 90).
Which companies have the most JDQ clearances?
Pioneer Surgical Technology (11); Synthes (Usa) (8); Howmedica Corp. (8); A & E Medical Corporation (4); Arthrex, Inc. (3).
Have JDQ devices been recalled?
Yes: 15 product recalls across 10 recall events; the most recent began 2019-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JDQ
- Run a recall and safety report across every JDQ manufacturer
- Watch product code JDQ 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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