FDA product code HRS: Plate, Fixation, Bone
HRS is the FDA product code for plate, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 1,326 510(k) submissions under HRS, 241 in the last five years, from 357 different applicants. The average 510(k) review took 115 days (median 86); 110 days on average over the last three years. FDA has posted 286 recalls for HRS devices, 59 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plate, 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 HRS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 57 | 135 |
| 2018 | 40 | 151 |
| 2019 | 46 | 120 |
| 2020 | 48 | 93 |
| 2021 | 40 | 135 |
| 2022 | 47 | 192 |
| 2023 | 40 | 155 |
| 2024 | 54 | 129 |
| 2025 | 54 | 117 |
| 2026 | 46 | 83 |
Compare with all 510(k) review times · Search every HRS clearance
Top HRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 87 | 2011-08-08 |
| Wrightmedicaltechnologyinc | 45 | 2021-01-08 |
| Arthrex, Inc. | 39 | 2026-03-03 |
| Smith & Nephew, Inc. | 34 | 2022-10-18 |
| Medartis AG | 31 | 2026-06-05 |
352 more applicants have HRS clearances. See the full list in Caduvo.
Most recent HRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262098 | Nvision Biomedical Technologies | EnHAnce PEEK Bunion System | 2026-09-18 | 88 |
| K262963 | Treace Medical Concepts, Inc. | TMC Implant Fixation System | 2026-09-15 | 21 |
| K261647 | Pace Surgical | Tempo Plating System; Ultra Compression Screw System | 2026-09-03 | 107 |
| K261830 | Ortler Global Tibbi Gerecler Anonim Sirketi | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | 2026-08-28 | 87 |
| K262537 | GM Dos Reis Industria e Comercio Ltda. | Versalock Sterile Plating System | 2026-08-19 | 27 |
Recalls for HRS devices
286 product recalls in 127 recall events; 59 initiated in the last five years and 54 still open. Most recent: 2026-05-28.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 32 |
| 2019 | 27 |
| 2020 | 30 |
| 2021 | 12 |
| 2022 | 4 |
| 2023 | 8 |
| 2024 | 2 |
| 2025 | 21 |
| 2026 | 16 |
Frequently asked questions
What is FDA product code HRS?
HRS is the FDA product code for plate, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is HRS?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRS?
Across 1,326 cleared submissions the average was 115 days from receipt to decision (median 86).
Which companies have the most HRS clearances?
Synthes (Usa) (87); Wrightmedicaltechnologyinc (45); Arthrex, Inc. (39); Smith & Nephew, Inc. (34); Medartis AG (31).
Have HRS devices been recalled?
Yes: 286 product recalls across 127 recall events; the most recent began 2026-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HRS
- Run a recall and safety report across every HRS manufacturer
- Watch product code HRS 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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