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) → HWC — Screw, Fixation, Bone # HWC · Screw, Fixation, Bone _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC ## Overview - **Product Code:** HWC - **Device Name:** Screw, Fixation, Bone - **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 1054) Showing 20 most recent of 1054 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260934](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K260934.md) | TITAN Nail; APTUS K-Wire System | Medartis AG | Apr 17, 2026 | SESE | | [K252699](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K252699.md) | CoAptix S System | University of Utah, Department of Orthopaedics | Apr 10, 2026 | SESE | | [K253042](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K253042.md) | Tyber Medical Trauma Screw | Tyber Medical, LLC | Apr 3, 2026 | SESE | | [K254110](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K254110.md) | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | Mar 18, 2026 | SESE | | [K260361](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K260361.md) | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | Mar 6, 2026 | SESE | | [K252901](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K252901.md) | Tyber Medical Trauma Screw | Tyber Medical, LLC | Dec 31, 2025 | SESE | | [K251555](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K251555.md) | Ultra™ Compression Screw System | Pace Surgical | Nov 6, 2025 | SESE | | [K252312](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K252312.md) | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | Oct 10, 2025 | SESE | | [K250536](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K250536.md) | MetaFore Small Screw System | Extremity Medical, LLC | Oct 8, 2025 | SESE | | [K252758](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K252758.md) | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | Oct 2, 2025 | SESE | | [K252019](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K252019.md) | CurvaFix Low Profile System | Curvafix, Inc. | Aug 29, 2025 | SESE | | [K251382](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K251382.md) | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | Aug 27, 2025 | SESE | | [K250867](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K250867.md) | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | Aug 15, 2025 | SESE | | [K250251](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K250251.md) | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | Jun 13, 2025 | SESE | | [K243943](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K243943.md) | TriMed® Compression Screws | TriMed, Inc. | Apr 10, 2025 | SESE | | [K250613](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K250613.md) | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | Apr 2, 2025 | SESE | | [K250304](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K250304.md) | TITANEX Screw Systems | Vilex, LLC | Mar 5, 2025 | SESE | | [K242896](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K242896.md) | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | Feb 5, 2025 | SESE | | [K242442](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K242442.md) | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | Jan 31, 2025 | SESE | | [K243195](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K243195.md) | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | Jan 10, 2025 | SESE | ## Top Applicants - Arthrex, Inc. — 44 clearances - Wrightmedicaltechnologyinc — 31 clearances - Synthes (Usa) — 30 clearances - Smith & Nephew, Inc. — 27 clearances - Biomet, Inc. — 24 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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