FDA product code · Orthopedic · Class 2
HRS: Plate, Fixation, Bone
HRS is FDA's product code for "Plate, 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 HRS
Across 416 510(k) clearances under HRS decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 59 and 172 days, and 80% were decided within 210 days. These are past clearances, not a forecast for a new submission.
| Fastest | 15 |
|---|---|
| 25th percentile | 59 |
| Median | 90 |
| 75th percentile | 172 |
| 80th percentile | 210 |
| 90th percentile | 266 |
| Slowest | 673 |
| Year | Median days | n |
|---|---|---|
| 2018 | 116 | 40 |
| 2019 | 89 | 46 |
| 2020 | 88 | 48 |
| 2021 | 87 | 40 |
| 2022 | 144 | 47 |
| 2023 | 120 | 40 |
| 2024 | 96 | 54 |
| 2025 | 90 | 54 |
| 2026 (to 10-06, partial) | 83 | 47 |
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.
HRS in the public FDA record
| 510(k) clearances, all years | 1,324 |
|---|---|
| Device recalls | 286 |
| Establishment listings | 4,935 |
| GUDID device identifiers | 86,512 |
Counts of records, not of devices or events. Adverse event reports for HRS 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 HRS
19 FDA recognized consensus standards cite HRS, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F564-17. 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
- 11-325 ASTM F564-17 — Standard Specification and Test Methods for Metallic Bone Staples
- 11-327 ASTM F543-17 — Standard Specification and Test Methods for Metallic Medical Bone Screws
- 11-333 ASTM F382-17 — Standard Specification and Test Method for Metallic Bone Plates
- 11-363 ASTM F897-19 — Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
- 11-378 ASTM F2502-17 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 11-413 ASTM F543-23 — Standard Specification and Test Methods for Metallic Medical Bone Screws
- 11-414 ASTM F382-24 — Standard Specification and Test Method for Metallic Bone Plates
- 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
- 11-438 ASTM F2502-24 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 11-439 ASTM F3437-23 — Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
- 8-475 ASTM F2026-17 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
The first 15 of 19 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.