Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) → HTY — Pin, Fixation, Smooth # HTY · Pin, Fixation, Smooth _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY ## Overview - **Product Code:** HTY - **Device Name:** Pin, Fixation, Smooth - **Regulation:** [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K253325.md) | ZipToe™ Hammertoe Fusion System | Toetal Solutions | Dec 29, 2025 | SESE | | [K252657](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K252657.md) | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | Sep 19, 2025 | SESE | | [K250315](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K250315.md) | RONAVIS – FX (FX-001) | AIRS, Inc. | Aug 1, 2025 | SESE | | [K251362](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K251362.md) | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | Jun 24, 2025 | SESE | | [K250646](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K250646.md) | Impact PEEK Union Nail System | Nvision Biomedical Technologies | Jun 11, 2025 | SESE | | [K241014](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K241014.md) | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | May 22, 2024 | SESE | | [K231272](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K231272.md) | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | Dec 1, 2023 | SESE | | [K231147](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K231147.md) | Hammerdesis™ Interphalangeal Fusion System | Intelivation | Sep 14, 2023 | SESE | | [K230750](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K230750.md) | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | Sep 13, 2023 | SESE | | [K231905](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K231905.md) | Electro-Spec Steri-Caps | Electro-Spec, Inc. | Aug 14, 2023 | SESE | | [K231339](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K231339.md) | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | Jul 6, 2023 | SESE | | [K221283](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K221283.md) | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | Sep 6, 2022 | SESE | | [K220906](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K220906.md) | SECURE-LOCK | Xiros, Ltd. | Jul 22, 2022 | SESE | | [K213982](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K213982.md) | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | Feb 17, 2022 | SESE | | [K211789](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K211789.md) | restor3d Pin Implants | Restor3D | Jan 4, 2022 | SESE | | [K211439](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K211439.md) | Small Bone Nailing System | Skeletal Dynamics, Inc. | Sep 30, 2021 | SESE | | [K203698](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203698.md) | CoLink Sfx Implant System | In2bones USA, LLC | May 4, 2021 | SESE | | [K203475](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203475.md) | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | Feb 5, 2021 | SESE | | [K201838](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K201838.md) | PediFlex Flexible Nail System | OrthoPediatrics Corp. | Jan 29, 2021 | SESE | | [K203465](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203465.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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