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) → JEC — Component, Traction, Invasive # JEC · Component, Traction, Invasive _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC ## Overview - **Product Code:** JEC - **Device Name:** Component, Traction, Invasive - **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 85) Showing 20 most recent of 85 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K203605](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K203605.md) | SteriTrak | Arbutus Medical, Inc. | Apr 23, 2021 | SESE | | [K193256](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K193256.md) | Anjon Bremer Halo System | Anjon Holdings, LLC | Mar 2, 2020 | SESE | | [K192465](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K192465.md) | DigiFix Sterile Kit | Virak Orthopedics, LLC | Oct 10, 2019 | SESE | | [K181192](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K181192.md) | PIP Fix | Hand Biomechanics Lab, Inc. | Oct 22, 2018 | SESE | | [K171863](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K171863.md) | Anjon Bremer Halo System | Anjon Holdings, LLC | Mar 19, 2018 | SESE | | [K163028](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K163028.md) | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | Dec 28, 2016 | SESE | | [K132731](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K132731.md) | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | Jan 10, 2014 | SESE | | [K102885](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K102885.md) | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX | Stryker Corp. | Jan 14, 2011 | SESE | | [K082679](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K082679.md) | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | Apr 7, 2009 | SESE | | [K072432](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K072432.md) | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | Jan 9, 2008 | SESE | | [K071476](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K071476.md) | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | Aug 24, 2007 | SESE | | [K042066](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K042066.md) | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | Aug 25, 2004 | SESE | | [K032427](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K032427.md) | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | Oct 9, 2003 | SESE | | [K031941](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K031941.md) | HOFFMANN II COMPACT BALTIMORE COUPLING | Howmedica Osteonics Corp. | Jul 24, 2003 | SESE | | [K030519](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K030519.md) | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Hand Biomechanics Lab, Inc. | Jun 10, 2003 | SESE | | [K022676](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K022676.md) | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | Sep 23, 2002 | SESE | | [K022065](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K022065.md) | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | Sintea Biotech, Inc. | Aug 6, 2002 | SESE | | [K012193](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K012193.md) | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | Smith & Nephew, Inc. | Jul 11, 2002 | SESE | | [K013818](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K013818.md) | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | Dec 5, 2001 | SESE | | [K003848](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K003848.md) | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST | Howmedica Osteonics Corp. | Jan 11, 2001 | SESE | ## Top Applicants - Howmedica Corp. — 11 clearances - Ace Orthopedic Manufacturing Co. — 5 clearances - Synthes (Usa) — 4 clearances - Hand Biomechanics Lab, Inc. — 4 clearances - Jerome Medical — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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