FDA product code HTY: Pin, Fixation, Smooth
HTY is the FDA product code for pin, fixation, smooth. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 205 510(k) submissions under HTY, 16 in the last five years, from 137 different applicants. The average 510(k) review took 113 days (median 85); 53 days on average over the last three years. FDA has posted 32 recalls for HTY devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pin, Fixation, Smooth |
| 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 HTY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 117 |
| 2018 | 4 | 162 |
| 2019 | 4 | 126 |
| 2020 | 5 | 147 |
| 2021 | 5 | 121 |
| 2022 | 4 | 127 |
| 2023 | 5 | 129 |
| 2024 | 1 | 40 |
| 2025 | 5 | 90 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every HTY clearance
Top HTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 13 | 2020-06-29 |
| OSSIO , Ltd. | 6 | 2023-12-01 |
| Biomet, Inc. | 5 | 2024-05-22 |
| Synthes (Usa) | 5 | 2001-04-09 |
| Bioretec, Ltd. | 4 | 2014-01-22 |
132 more applicants have HTY clearances. See the full list in Caduvo.
Most recent HTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262722 | Paragon 28, Inc. | Primal K-Wire (P99-193-1410) | 2026-08-28 | 28 |
| K253325 | Toetal Solutions | ZipToe Hammertoe Fusion System | 2025-12-29 | 90 |
| K252657 | Nvision Biomedical Technologies, Inc. | Impact PEEK Union Nail System | 2025-09-19 | 28 |
| K250315 | AIRS, Inc. | RONAVIS FX (FX-001) | 2025-08-01 | 178 |
| K251362 | OrthoPediatrics Corp. | PediFlex Flexible Nail System | 2025-06-24 | 54 |
Recalls for HTY devices
32 product recalls in 18 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2026-06-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 13 |
| 2019 | 2 |
| 2022 | 3 |
| 2024 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HTY?
HTY is the FDA product code for pin, fixation, smooth. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is HTY?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code HTY?
Across 205 cleared submissions the average was 113 days from receipt to decision (median 85).
Which companies have the most HTY clearances?
Arthrex, Inc. (13); OSSIO , Ltd. (6); Biomet, Inc. (5); Synthes (Usa) (5); Bioretec, Ltd. (4).
Have HTY devices been recalled?
Yes: 32 product recalls across 18 recall events; the most recent began 2026-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code HTY
- Run a recall and safety report across every HTY manufacturer
- Watch product code HTY 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times