Product code HWC: 510(k) clearances and predicates
Product code HWC covers Arthrex Beaming System. FDA lists 1068 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
1068 clearances on file under product code HWC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 26 |
| 2023 | 24 |
| 2024 | 17 |
| 2025 | 15 |
| 2026 so far | 19 |
Recent clearances
Newest HWC clearances in the FDA index, with applicant and decision date:
- K262975, Arthrex Beaming System, applicant Arthrex, Inc., decided 2026-09-25. FDA record
- K260995, DynaNail Helix® Fixation System, applicant MedShape, Inc., decided 2026-09-23. FDA record
- K254280, F.A.S.T Screw, applicant Steps Ortho, decided 2026-09-21. FDA record
- K261057, ActivaScrew Cannulated COM, applicant Bioretec, Ltd., decided 2026-09-04. FDA record
- K260106, OsteoCoil GT Active Compression System, applicant Flower Orthopedics Corporation DBA Conventus Flower Orthoped, decided 2026-08-24. FDA record
- K262344, Large Compression Screws, applicant TriMed, Inc., decided 2026-08-12. FDA record
- K253858, GFS - Sterile Screws and Top Hat, applicant T.A.G. Medical Products Corporation, Ltd., decided 2026-08-05. FDA record
- K262075, Lapidus Screw Kit, applicant Relja Innovations, LLC, decided 2026-07-22. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include DynaNail Helix® Fixation System, F.A.S.T Screw. Watch new HWC clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HWC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HWC clearances include Arthrex Beaming System.
How many 510(k) clearances use product code HWC?
1068 at the time this page was generated, from openFDA records.
How do I find a predicate device under HWC?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HWC clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.