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) → JDW — Pin, Fixation, Threaded # JDW · Pin, Fixation, Threaded _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW ## Overview - **Product Code:** JDW - **Device Name:** Pin, Fixation, Threaded - **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 94) Showing 20 most recent of 94 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260073](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K260073.md) | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | Feb 10, 2026 | SESE | | [K250316](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K250316.md) | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | Oct 29, 2025 | SESE | | [K241357](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K241357.md) | XT3 System | Biodynamik, Inc. | Jan 22, 2025 | SESE | | [K223112](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K223112.md) | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | Dec 8, 2022 | SESE | | [K213874](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K213874.md) | MAVERICK External Fixation System | Smith & Nephew, Inc. | Feb 11, 2022 | SESE | | [K211508](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K211508.md) | Steinmann Pins and Kirschner Wires | Stryker GmbH | Oct 5, 2021 | SESE | | [K210784](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K210784.md) | Extended HA Half Pins | Smith & Nephew, Inc. | Apr 2, 2021 | SESE | | [K200933](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K200933.md) | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | May 5, 2020 | SESE | | [K191803](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K191803.md) | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | Apr 14, 2020 | SESE | | [K192768](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K192768.md) | Temporary Fixation Pins | Eisertech, LLC | Dec 26, 2019 | SESE | | [K182171](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K182171.md) | SMV Scientific K-Wire and Pins | Summit Medventures | Oct 25, 2018 | SESE | | [K163487](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K163487.md) | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | Feb 13, 2017 | SESE | | [K150661](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K150661.md) | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | Jul 7, 2015 | SESE | | [K132820](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K132820.md) | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | Jul 23, 2014 | SESE | | [K140875](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K140875.md) | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | May 30, 2014 | SESE | | [K131459](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K131459.md) | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | Oct 17, 2013 | SESE | | [K130298](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K130298.md) | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | Jun 18, 2013 | SESE | | [K120871](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K120871.md) | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | Jun 7, 2012 | SESE | | [K103001](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K103001.md) | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | Feb 17, 2011 | SESE | | [K102777](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K102777.md) | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | Dec 20, 2010 | SESE | ## Top Applicants - Smith & Nephew, Inc. — 8 clearances - Depuy, Inc. — 5 clearances - Biomet, Inc. — 4 clearances - Buckman Co., Inc. — 4 clearances - Synthes (Usa) — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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