FDA product code · Orthopedic · Class 2
JDR: Staple, Fixation, Bone
JDR is FDA's product code for "Staple, Fixation, Bone": a Class 2 device classified under 21 CFR 888.3030, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for JDR
Across 43 510(k) clearances under JDR decided from 2018-01-01 to 2026-10-06, the median was 84 days from FDA receipt to decision. Half took between 53 and 146 days, and 80% were decided within 149 days. These are past clearances, not a forecast for a new submission.
| Fastest | 19 |
|---|---|
| 25th percentile | 53 |
| Median | 84 |
| 75th percentile | 146 |
| 80th percentile | 149 |
| 90th percentile | 172 |
| Slowest | 469 |
| Year | Median days | n |
|---|---|---|
| 2018 | 107 | 8 |
| 2019 | 149 | 5 |
| 2022 | 107 | 5 |
| 2023 | 72 | 9 |
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.
JDR in the public FDA record
| 510(k) clearances, all years | 233 |
|---|---|
| Device recalls | 36 |
| Establishment listings | 690 |
| GUDID device identifiers | 2,275 |
Counts of records, not of devices or events. Adverse event reports for JDR 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 JDR
7 FDA recognized consensus standards cite JDR, 1 of them recognized only in part, among them ISO 8827 First edition 1988-10-15; ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-184 ISO 8827 First edition 1988-10-15 (partial recognition) — Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
- 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
- 11-325 ASTM F564-17 — Standard Specification and Test Methods for Metallic Bone Staples
- 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
- 11-430 ASTM F564-24 — Standard Specification and Test Methods for Metallic Bone Staples
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.