Product code HRS: 510(k) clearances and predicates
Product code HRS covers ProRib Fixation System. FDA lists 1327 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
1327 clearances on file under product code HRS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 47 |
| 2023 | 40 |
| 2024 | 54 |
| 2025 | 54 |
| 2026 so far | 47 |
Recent clearances
Newest HRS clearances in the FDA index, with applicant and decision date:
- K261892, ProRib Fixation System, applicant Costa Surgical, Inc., decided 2026-09-23. FDA record
- K262098, EnHAnce PEEK Bunion System, applicant Nvision Biomedical Technologies, decided 2026-09-18. FDA record
- K262963, TMC Implant Fixation System, applicant Treace Medical Concepts, Inc., decided 2026-09-15. FDA record
- K261647, Tempo Plating System; Ultra Compression Screw System, applicant Pace Surgical, decided 2026-09-03. FDA record
- K261830, 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), applicant Ortler Global Tibbi Gerecler Anonim Sirketi, decided 2026-08-28. FDA record
- K262537, Versalock Sterile Plating System, applicant GM Dos Reis Industria e Comercio Ltda., decided 2026-08-19. FDA record
- K260277, MIKRON TRAUMA BONE PLATE& SCREW SYSTEM, applicant Mikron Makina San. ve Tic. Ltd. Sti., decided 2026-08-13. FDA record
- K261511, Xpert Ankle, applicant Newclip Technics, decided 2026-07-28. 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 EnHAnce PEEK Bunion System, TMC Implant Fixation System. Watch new HRS 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 HRS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HRS clearances include ProRib Fixation System.
How many 510(k) clearances use product code HRS?
1327 at the time this page was generated, from openFDA records.
How do I find a predicate device under HRS?
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 HRS clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for HRS, 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 HRS brief
Tell us where to send it. No card required.
You are on the list.
We will email your free HRS brief shortly. HRS 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.