Product code HTY: 510(k) clearances and predicates
Product code HTY covers Impact PEEK Union Nail System. FDA lists 205 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
205 clearances on file under product code HTY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 so far | 1 |
Recent clearances
Newest HTY clearances in the FDA index, with applicant and decision date:
- K262722, Primal K-Wire (P99-193-1410), applicant Paragon 28, Inc., decided 2026-08-28. FDA record
- K253325, ZipToe Hammertoe Fusion System, applicant Toetal Solutions, decided 2025-12-29. FDA record
- K252657, Impact PEEK Union Nail System, applicant Nvision Biomedical Technologies, Inc., decided 2025-09-19. FDA record
- K250315, RONAVIS FX (FX-001), applicant AIRS, Inc., decided 2025-08-01. FDA record
- K251362, PediFlex Flexible Nail System, applicant OrthoPediatrics Corp., decided 2025-06-24. FDA record
- K250646, Impact PEEK Union Nail System, applicant Nvision Biomedical Technologies, decided 2025-06-11. FDA record
- K241014, Biomet Kirschner Wires (K-Wires), applicant Biomet, Inc., decided 2024-05-22. FDA record
- K231272, OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail, applicant OSSIO , Ltd., decided 2023-12-01. 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 Primal K-Wire (P99-193-1410), ZipToe Hammertoe Fusion System. Watch new HTY 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 HTY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HTY clearances include Impact PEEK Union Nail System.
How many 510(k) clearances use product code HTY?
205 at the time this page was generated, from openFDA records.
How do I find a predicate device under HTY?
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 HTY clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for HTY, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free HTY brief
Tell us where to send it. No card required.
You are on the list.
We will email your free HTY brief shortly. HTY is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.