FDA product code HWC: Screw, Fixation, Bone
HWC is the FDA product code for screw, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 1,065 510(k) submissions under HWC, 98 in the last five years, from 383 different applicants. The average 510(k) review took 115 days (median 88); 126 days on average over the last three years. FDA has posted 388 recalls for HWC devices, 47 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Screw, Fixation, Bone |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HWC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 40 | 156 |
| 2018 | 20 | 130 |
| 2019 | 30 | 132 |
| 2020 | 28 | 91 |
| 2021 | 26 | 122 |
| 2022 | 26 | 180 |
| 2023 | 24 | 114 |
| 2024 | 17 | 147 |
| 2025 | 15 | 110 |
| 2026 | 16 | 122 |
Compare with all 510(k) review times · Search every HWC clearance
Top HWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 46 | 2026-06-25 |
| Wrightmedicaltechnologyinc | 31 | 2021-11-16 |
| Synthes (Usa) | 30 | 2010-01-11 |
| Smith & Nephew, Inc. | 27 | 2023-12-21 |
| Biomet, Inc. | 24 | 2020-02-24 |
378 more applicants have HWC clearances. See the full list in Caduvo.
Most recent HWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261057 | Bioretec, Ltd. | ActivaScrew Cannulated COM | 2026-09-04 | 157 |
| K260106 | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | OsteoCoil GT Active Compression System | 2026-08-24 | 222 |
| K262344 | TriMed, Inc. | Large Compression Screws | 2026-08-12 | 33 |
| K253858 | T.A.G. Medical Products Corporation, Ltd. | GFS - Sterile Screws and Top Hat | 2026-08-05 | 245 |
| K262075 | Relja Innovations, LLC | Lapidus Screw Kit | 2026-07-22 | 30 |
Recalls for HWC devices
388 product recalls in 135 recall events; 47 initiated in the last five years and 37 still open. Most recent: 2026-04-24.
| Year | Recalls |
|---|---|
| 2017 | 13 |
| 2018 | 22 |
| 2019 | 12 |
| 2020 | 7 |
| 2021 | 5 |
| 2022 | 13 |
| 2024 | 26 |
| 2025 | 1 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code HWC?
HWC is the FDA product code for screw, fixation, bone. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is HWC?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code HWC?
Across 1,065 cleared submissions the average was 115 days from receipt to decision (median 88).
Which companies have the most HWC clearances?
Arthrex, Inc. (46); Wrightmedicaltechnologyinc (31); Synthes (Usa) (30); Smith & Nephew, Inc. (27); Biomet, Inc. (24).
Have HWC devices been recalled?
Yes: 388 product recalls across 135 recall events; the most recent began 2026-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HWC
- Run a recall and safety report across every HWC manufacturer
- Watch product code HWC 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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