HTY
- Product code
- HTY
- Device name
- Pin, Fixation, Smooth
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 205 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262722 | 2026-08-28 | Paragon 28, Inc. | Primal K-Wire (P99-193-1410) | |
| K253325 | 2025-12-29 | Toetal Solutions | ZipToe Hammertoe Fusion System | |
| K252657 | 2025-09-19 | Nvision Biomedical Technologies, Inc. | Impact PEEK Union Nail System | |
| K250315 | 2025-08-01 | AIRS, Inc. | RONAVIS FX (FX-001) | |
| K251362 | 2025-06-24 | OrthoPediatrics Corp. | PediFlex Flexible Nail System | |
| K250646 | 2025-06-11 | Nvision Biomedical Technologies | Impact PEEK Union Nail System | |
| K241014 | 2024-05-22 | Biomet, Inc. | Biomet Kirschner Wires (K-Wires) | |
| K231272 | 2023-12-01 | OSSIO , Ltd. | OSSIOfiber® Pin Product Family, OSSIOfiber® Compress… | |
| K231147 | 2023-09-14 | Intelivation | Hammerdesis Interphalangeal Fusion System | |
| K230750 | 2023-09-13 | OSSIO , Ltd. | OSSIOfiber® Cannulated Trimmable Fixation Nail |
Official FDA classification page: HTY
Classification and pathway per current FDA publications. Data from openFDA (CC0).