FDA product code · Orthopedic · Class 2
JDQ: Cerclage, Fixation
JDQ is FDA's product code for "Cerclage, Fixation": a Class 2 device classified under 21 CFR 888.3010, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for JDQ
Across 21 510(k) clearances under JDQ decided from 2018-01-01 to 2026-10-06, the median was 118 days from FDA receipt to decision. Half took between 88 and 238 days, and 80% were decided within 238 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 88 |
| Median | 118 |
| 75th percentile | 238 |
| 80th percentile | 238 |
| 90th percentile | 266 |
| Slowest | 497 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
JDQ in the public FDA record
| 510(k) clearances, all years | 130 |
|---|---|
| Device recalls | 15 |
| Establishment listings | 372 |
| GUDID device identifiers | 950 |
Counts of records, not of devices or events. Adverse event reports for JDQ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite JDQ
6 FDA recognized consensus standards cite JDQ, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F2180-17. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-329 ASTM F2180-17 — Standard Specification for Metallic Implantable Strands and Cables
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-432 ASTM F2180-24 — Standard Specification for Metallic Implantable Strands and Cables
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.