HTY — Pin, Fixation, Smooth Class II
FDA product code HTY covers "Pin, Fixation, Smooth", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HTY
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253325 | toetal solutions | ZipToe Hammertoe Fusion System | December 29, 2025 |
| K252657 | nvision biomedical technologies | Impact PEEK Union Nail System | September 19, 2025 |
| K250315 | airs | RONAVIS FX (FX-001) | August 1, 2025 |
| K251362 | orthopediatrics | PediFlex Flexible Nail System | June 24, 2025 |
| K250646 | nvision biomedical technologies | Impact PEEK Union Nail System | June 11, 2025 |
| K241014 | biomet | Biomet Kirschner Wires (K-Wires) | May 22, 2024 |
| K231272 | ossio | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm | December 1, 2023 |
| K231147 | intelivation | Hammerdesis Interphalangeal Fusion System | September 14, 2023 |
| K230750 | ossio | OSSIOfiber® Cannulated Trimmable Fixation Nail | September 13, 2023 |
| K231905 | electro-spec | Electro-Spec Steri-Caps | August 14, 2023 |
| K231339 | tyber medical | Tyber Medical Pin and Wire System (various) | July 6, 2023 |
| K221283 | 4web medical | Hammertoe Truss System (HTS) | September 6, 2022 |
| K220906 | xiros | SECURE-LOCK | July 22, 2022 |
| K213982 | pacific instruments | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | February 17, 2022 |
| K211789 | restor3d | restor3d Pin Implants | January 4, 2022 |
| K211439 | skeletal dynamics | Small Bone Nailing System | September 30, 2021 |
| K203698 | in2bones usa | CoLink Sfx Implant System | May 4, 2021 |
| K203475 | lima corporate | LimaCorporate Kirschner Wire | February 5, 2021 |
| K201838 | orthopediatrics | PediFlex Flexible Nail System | January 29, 2021 |
| K203465 | ossio | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nai | January 6, 2021 |