HTY — Pin, Fixation, Smooth Class II
FDA Device Classification
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 |