JEC · Component, Traction, Invasive
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | JEC |
|---|---|
| Device Name | Component, Traction, Invasive |
| 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 85)
Showing 20 most recent of 85 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203605 | SteriTrak | Arbutus Medical, Inc. | Apr 23, 2021 | SESE |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | Mar 2, 2020 | SESE |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | Oct 10, 2019 | SESE |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | Oct 22, 2018 | SESE |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | Mar 19, 2018 | SESE |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | Dec 28, 2016 | SESE |
| K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | Jan 10, 2014 | SESE |
| K102885 | 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 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | Apr 7, 2009 | SESE |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | Jan 9, 2008 | SESE |
| K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | Aug 24, 2007 | SESE |
| K042066 | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | Aug 25, 2004 | SESE |
| K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | Oct 9, 2003 | SESE |
| K031941 | HOFFMANN II COMPACT BALTIMORE COUPLING | Howmedica Osteonics Corp. | Jul 24, 2003 | SESE |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Hand Biomechanics Lab, Inc. | Jun 10, 2003 | SESE |
| K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | Sep 23, 2002 | SESE |
| K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | Sintea Biotech, Inc. | Aug 6, 2002 | SESE |
| K012193 | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | Smith & Nephew, Inc. | Jul 11, 2002 | SESE |
| K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | Dec 5, 2001 | SESE |
| K003848 | 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
