HTY · Pin, Fixation, Smooth
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | HTY |
|---|---|
| Device Name | Pin, Fixation, Smooth |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 204)
Showing 20 most recent of 204 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | Dec 29, 2025 | SESE |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | Sep 19, 2025 | SESE |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | Aug 1, 2025 | SESE |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | Jun 24, 2025 | SESE |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | Jun 11, 2025 | SESE |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | May 22, 2024 | SESE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | Dec 1, 2023 | SESE |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | Sep 14, 2023 | SESE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | Sep 13, 2023 | SESE |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | Aug 14, 2023 | SESE |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | Jul 6, 2023 | SESE |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | Sep 6, 2022 | SESE |
| K220906 | SECURE-LOCK | Xiros, Ltd. | Jul 22, 2022 | SESE |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | Feb 17, 2022 | SESE |
| K211789 | restor3d Pin Implants | Restor3D | Jan 4, 2022 | SESE |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | Sep 30, 2021 | SESE |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | May 4, 2021 | SESE |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | Feb 5, 2021 | SESE |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | Jan 29, 2021 | SESE |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design | OSSIO , Ltd. | Jan 6, 2021 | SESE |
Top Applicants
- Arthrex, Inc. — 13 clearances
- OSSIO , Ltd. — 6 clearances
- Biomet, Inc. — 5 clearances
- Synthes (Usa) — 5 clearances
- Bioretec, Ltd. — 4 clearances
