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.
Cleared Devices (85)
| 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 |
| K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN | Depuyacromed | Dec 15, 1999 | SESE |
| K991732 | CENTRAFIX EXTERNAL FIXATOR | Owandar Medical, Ltd. | May 21, 1999 | SESE |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | Hand Biomechanics Lab, Inc. | Feb 12, 1999 | SESE |
| K981423 | AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 | Autogenesis, Inc. | May 20, 1998 | SESE |
| K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM | Howmedica Corp. | Jul 17, 1997 | SESE |
| K965029 | STABLELOC II EXTERNAL FIXATOR | Acu Med, Inc. | Feb 19, 1997 | SESE |
| K963614 | MONOTUBE CARBON TUBE | Howmedica Corp. | Nov 6, 1996 | SESE |
| K961916 | HOFFMANN II CARBON CONNECTING ROD | Howmedica, Inc. | Aug 1, 1996 | SESE |
| K961618 | MONOTUBE TUBE TO RING CLAMP | Howmedica Corp. | May 28, 1996 | SESE |
| K960782 | TITANIUM TUBE TO TUBE CLAMP | Synthes (Usa) | May 8, 1996 | SESE |
| K954838 | EZ FIX | Biodynamic Technologies, Inc. | Jan 24, 1996 | SESE |
| K954667 | MONOTUBE TUBE-TO-TUBE CLAMP | Howmedica Corp. | Jan 11, 1996 | SESE |
| K952330 | EXTERNAL FIXATOR | Acu Med, Inc. | Oct 5, 1995 | SESE |
| K952730 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Corp. | Sep 8, 1995 | SESE |
| K944092 | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM | Orthofix Srl | Apr 4, 1995 | SESE |
| K943857 | EXTERNAL FIXATOR | Acu Med, Inc. | Jan 27, 1995 | SN |
| K933968 | ACE PELVIC STABILIZER | Ace Medical Co. | Jun 16, 1994 | SESE |
| K922796 | PELVIC C-CLAMP | Synthes (Usa) | Mar 10, 1994 | SESE |
| K936124 | HOWMEDICA MONOTUBE T-CONNECTOR | Howmedica, Inc. | Feb 22, 1994 | SESE |
| K936045 | ACE UNILATERAL FIXATOR II | Ace Orthopedic Manufacturing Co. | Feb 22, 1994 | SESE |
| K934698 | HOWMEDICA MONO-TUBE SINGLE PIN CLAMP | Howmedica Corp. | Feb 22, 1994 | SESE |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Applied Osteo Systems, Inc. | Feb 22, 1994 | SESE |
| K930153 | SYSTEM III HALO RING | Jerome Medical | Aug 6, 1993 | SESE |
| K920117 | HALO ESPRIT | Itm Corp. | Oct 6, 1992 | SESE |
| K920149 | OSTEO EX-FI-RE | Osteo AG | Apr 9, 1992 | SESE |
| K915800 | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN | Bremer Medical, Inc. | Mar 16, 1992 | SESE |
| K914858 | ACE OPEN-BACK HALO RING | Ace Medical Co. | Nov 21, 1991 | SESE |
| K894959 | CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO | Alphatec Mfg., Inc. | Sep 14, 1990 | SESE |
| K903105 | OLIVE K-WIRES | Danek Medical, Inc. | Sep 6, 1990 | SESE |
| K901984 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | Jun 21, 1990 | SESE |
| K894098 | SYNTHES EXTERNAL FIXATION BONE CLIP | Synthes (Usa) | Apr 30, 1990 | SESE |
| K894982 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | Jan 11, 1990 | SESE |
| K892638 | TRACER DYNAMIC AXIAL FIXATION | Tracer Medical | Aug 11, 1989 | SESE |
| K884798 | AME PINSITE SHIELD(TM) | American Medical Electronics, Inc. | Feb 10, 1989 | SESE |
| K884242 | MODIFIED CHICK AMBULATORY HALO | Chick Medical Products | Dec 29, 1988 | SESE |
| K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE | Jerome Medical | Sep 30, 1988 | SESE |
| K881896 | KIRSCHNER SUPER-FIXATION SYSTEM | Kirschner Medical Corp. | Jul 28, 1988 | SESE |
| K881673 | LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER | Lima-Lto, Inc. | Jun 3, 1988 | SESE |
| K880282 | LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER | Lima-Lto, Inc. | Feb 18, 1988 | SESE |
| K872538 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS | Vitaphore Corp. | Jul 10, 1987 | SESE |
| K852397 | EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) | Howmedica Corp. | Aug 9, 1985 | SESE |
| K842493 | AGEE EXTERNAL FIXATOR | The Hand Biomechanics Research Laboratory | Feb 13, 1985 | SESE |
| K842343 | SABA-COOMBS MINI EXTERNAL FIXATOR | Zimmer, Inc. | Sep 11, 1984 | SESE |
| K841334 | RICHARDS FIXATOR SYSTEM | Richards Medical Co., Inc. | May 16, 1984 | SESE |
| K840856 | MODULAR CONSTRUCT FRAME EXTERNAL FIXA | Precision Medical Devices, Inc. | Apr 25, 1984 | SESE |
| K833114 | OXFORD MARK 2 EXTERNAL FIXATOR | Johnson & Johnson Professionals, Inc. | Oct 20, 1983 | SESE |
| K831576 | ORTHOFIX | Electro-Biology, Inc. | Jun 8, 1983 | SESE |
| K830154 | COLLES FRACTURE FRAME | Richard'S Medical Equip., Inc. | Feb 2, 1983 | SESE |
| K822780 | CERVICAL BRACE | Jerome Medical | Oct 6, 1982 | SESE |
| K803166 | DOUBLE BALL JOINT | Howmedica Corp. | Jan 9, 1981 | SESE |
| K802814 | ORTHOFIX AXIALEXTERNAL FIXATION SYS. | Cintor Orthopaedic Div. | Dec 10, 1980 | SESE |
| K802776 | HOFFMAN LEG LENGTHENING DEVICE | Howmedica Corp. | Nov 19, 1980 | SESE |
| K802723 | EXTENDED BALLJOINT GRIP | Howmedica Corp. | Nov 19, 1980 | SESE |
| K802722 | EXTERNAL FIXATION SYSTEM | Howmedica Corp. | Nov 19, 1980 | SESE |
| K800184 | OXFORD EXTERNAL FIXATION SYSTEM | Downs Surgical , Ltd. | Feb 11, 1980 | SESE |
| K792561 | MINI-H-FIXATION | Geny Medical, Inc. | Dec 19, 1979 | SESE |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | Ace Orthopedic Manufacturing Co. | Aug 16, 1979 | SESE |
| K790262 | UNIVERSAL EXTERNAL FIXATION ASSEMBLY | Zimmer, Inc. | Feb 13, 1979 | SESE |
| K781841 | BAR, DISTRACTION | Ace Orthopedic Manufacturing Co. | Nov 8, 1978 | SESE |
| K781840 | EXTERNAL ARTICULATION | Ace Orthopedic Manufacturing Co. | Nov 8, 1978 | SESE |
| K781839 | BONE CLAMP, ACE EXTERNAL | Ace Orthopedic Manufacturing Co. | Nov 8, 1978 | SESE |
| K781793 | FRAME, UNIVERSAL DAY | B.G. Orthopedic Corp. | Nov 3, 1978 | SESE |
| K770066 | TIBIAL COMPRESSION FRAM FOR FRACTURES | Richard F. Kronner, M.D. | Mar 30, 1977 | SESE |
| K770388 | FRACTURE REDUCTION SYS., MODEL OR 1001 | Sisan Assoc. | Mar 14, 1977 | SESE |
| K761088 | DEPUY MODIFIED SKELETAL TRACTION PIN | Depuy, Inc. | Dec 17, 1976 | 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
