Product Code: JEC FDA class 2 21 CFR 888.3040

Component, Traction, Invasive

Orthopedic

An Invasive Traction Component is an orthopedic device inserted percutaneously or surgically into bone to apply traction forces for fracture reduction, limb lengthening, or skeletal alignment, typically as part of a larger traction system. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JEC, regulated under 21 CFR 888.3040, within the Orthopedic medical specialty. This device is flagged as an implant because it involves penetration into osseous tissue.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JEC
Device Class: FDA class 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 85 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203605	SteriTrak	Apr 23, 2021	Substantially Equivalent	Arbutus Medical, Inc.
K193256	Anjon Bremer Halo System	Mar 02, 2020	Substantially Equivalent	Anjon Holdings, LLC
K192465	DigiFix Sterile Kit	Oct 10, 2019	Substantially Equivalent	Virak Orthopedics, LLC
K181192	PIP Fix	Oct 22, 2018	Substantially Equivalent	Hand Biomechanics Lab, Inc.
K171863	Anjon Bremer Halo System	Mar 19, 2018	Substantially Equivalent	Anjon Holdings, LLC
K163028	Medline ReNewal Reprocessed Stryker External Fixation Devices	Dec 28, 2016	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K132731	DIGIFIX EXTERNAL FIXATION SYSTEM	Jan 10, 2014	Substantially Equivalent	Virak Orthopedic Research, LLC
K102885	HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX	Jan 14, 2011	Substantially Equivalent	Stryker Corp.
K082679	LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X	Apr 07, 2009	Substantially Equivalent	Sintea Biotech, Inc.
K072432	F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE	Jan 09, 2008	Substantially Equivalent	Hand Biomechanics Lab, Inc.
K071476	SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP	Aug 24, 2007	Substantially Equivalent	Synthes (Usa)
K042066	KLSA MARTIN HAND DISTRACTOR	Aug 25, 2004	Substantially Equivalent	KLS-Martin L.P.
K032427	FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM	Oct 09, 2003	Substantially Equivalent	Meridan Medical
K031941	HOFFMANN II COMPACT BALTIMORE COUPLING	Jul 24, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K030519	WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS	Jun 10, 2003	Substantially Equivalent	Hand Biomechanics Lab, Inc.
K022676	ORTHOGUARD AB ANTIMICROBIAL SLEEVE	Sep 23, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K022065	SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X	Aug 06, 2002	Substantially Equivalent	Sintea Biotech, Inc.
K012193	AMC ANTIMICROBIAL PIN/WIRE SLEEVE	Jul 11, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K013818	AUTOGENESIS AUTOMATOR, MODEL M1000	Dec 05, 2001	Substantially Equivalent	Autogenesis, Inc.
K003848	HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST	Jan 11, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K993099	BREMER HALO SYSTEM TITANIUM SKULL PIN	Dec 15, 1999	Substantially Equivalent	Depuyacromed
K991732	CENTRAFIX EXTERNAL FIXATOR	May 21, 1999	Substantially Equivalent	Owandar Medical, Ltd.
K984442	AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147	Feb 12, 1999	Substantially Equivalent	Hand Biomechanics Lab, Inc.
K981423	AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000	May 20, 1998	Substantially Equivalent	Autogenesis, Inc.
K971755	HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM	Jul 17, 1997	Substantially Equivalent	Howmedica Corp.
K965029	STABLELOC II EXTERNAL FIXATOR	Feb 19, 1997	Substantially Equivalent	Acu Med, Inc.
K963614	MONOTUBE CARBON TUBE	Nov 06, 1996	Substantially Equivalent	Howmedica Corp.
K961916	HOFFMANN II CARBON CONNECTING ROD	Aug 01, 1996	Substantially Equivalent	Howmedica, Inc.
K961618	MONOTUBE TUBE TO RING CLAMP	May 28, 1996	Substantially Equivalent	Howmedica Corp.
K960782	TITANIUM TUBE TO TUBE CLAMP	May 08, 1996	Substantially Equivalent	Synthes (Usa)
K954838	EZ FIX	Jan 24, 1996	Substantially Equivalent	Biodynamic Technologies, Inc.
K954667	MONOTUBE TUBE-TO-TUBE CLAMP	Jan 11, 1996	Substantially Equivalent	Howmedica Corp.
K952330	EXTERNAL FIXATOR	Oct 05, 1995	Substantially Equivalent	Acu Med, Inc.
K952730	HOFFMANN II EXTERNAL FIXATION SYSTEM	Sep 08, 1995	Substantially Equivalent	Howmedica Corp.
K944092	ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM	Apr 04, 1995	Substantially Equivalent	Orthofix Srl
K943857	EXTERNAL FIXATOR	Jan 27, 1995	Substantially Equivalent for Some Indications	Acu Med, Inc.
K933968	ACE PELVIC STABILIZER	Jun 16, 1994	Substantially Equivalent	Ace Medical Co.
K922796	PELVIC C-CLAMP	Mar 10, 1994	Substantially Equivalent	Synthes (Usa)
K936124	HOWMEDICA MONOTUBE T-CONNECTOR	Feb 22, 1994	Substantially Equivalent	Howmedica, Inc.
K936045	ACE UNILATERAL FIXATOR II	Feb 22, 1994	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K934698	HOWMEDICA MONO-TUBE SINGLE PIN CLAMP	Feb 22, 1994	Substantially Equivalent	Howmedica Corp.
K931578	TEXAS SCOTTISH RITE EASY/LOCK FIXATOR	Feb 22, 1994	Substantially Equivalent	Applied Osteo Systems, Inc.
K930153	SYSTEM III HALO RING	Aug 06, 1993	Substantially Equivalent	Jerome Medical
K920117	HALO ESPRIT	Oct 06, 1992	Substantially Equivalent	Itm Corp.
K920149	OSTEO EX-FI-RE	Apr 09, 1992	Substantially Equivalent	Osteo AG
K915800	BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN	Mar 16, 1992	Substantially Equivalent	Bremer Medical, Inc.
K914858	ACE OPEN-BACK HALO RING	Nov 21, 1991	Substantially Equivalent	Ace Medical Co.
K894959	CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO	Sep 14, 1990	Substantially Equivalent	Alphatec Mfg., Inc.
K903105	OLIVE K-WIRES	Sep 06, 1990	Substantially Equivalent	Danek Medical, Inc.
K901984	ACE WIRE TENSION CLAMP	Jun 21, 1990	Substantially Equivalent	Buckman Co., Inc.
K894098	SYNTHES EXTERNAL FIXATION BONE CLIP	Apr 30, 1990	Substantially Equivalent	Synthes (Usa)
K894982	ACE WIRE TENSION CLAMP	Jan 11, 1990	Substantially Equivalent	Buckman Co., Inc.
K892638	TRACER DYNAMIC AXIAL FIXATION	Aug 11, 1989	Substantially Equivalent	Tracer Medical
K884798	AME PINSITE SHIELD(TM)	Feb 10, 1989	Substantially Equivalent	American Medical Electronics, Inc.
K884242	MODIFIED CHICK AMBULATORY HALO	Dec 29, 1988	Substantially Equivalent	Chick Medical Products
K882877	JMS CERVICAL TRACTION DEVICE/HALO DEVICE	Sep 30, 1988	Substantially Equivalent	Jerome Medical
K881896	KIRSCHNER SUPER-FIXATION SYSTEM	Jul 28, 1988	Substantially Equivalent	Kirschner Medical Corp.
K881673	LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER	Jun 03, 1988	Substantially Equivalent	Lima-Lto, Inc.
K880282	LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER	Feb 18, 1988	Substantially Equivalent	Lima-Lto, Inc.
K872538	VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS	Jul 10, 1987	Substantially Equivalent	Vitaphore Corp.
K852397	EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)	Aug 09, 1985	Substantially Equivalent	Howmedica Corp.
K842493	AGEE EXTERNAL FIXATOR	Feb 13, 1985	Substantially Equivalent	The Hand Biomechanics Research Laboratory
K842343	SABA-COOMBS MINI EXTERNAL FIXATOR	Sep 11, 1984	Substantially Equivalent	Zimmer, Inc.
K841334	RICHARDS FIXATOR SYSTEM	May 16, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K840856	MODULAR CONSTRUCT FRAME EXTERNAL FIXA	Apr 25, 1984	Substantially Equivalent	Precision Medical Devices, Inc.
K833114	OXFORD MARK 2 EXTERNAL FIXATOR	Oct 20, 1983	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K831576	ORTHOFIX	Jun 08, 1983	Substantially Equivalent	Electro-Biology, Inc.
K830154	COLLES FRACTURE FRAME	Feb 02, 1983	Substantially Equivalent	Richard'S Medical Equip., Inc.
K822780	CERVICAL BRACE	Oct 06, 1982	Substantially Equivalent	Jerome Medical
K803166	DOUBLE BALL JOINT	Jan 09, 1981	Substantially Equivalent	Howmedica Corp.
K802814	ORTHOFIX AXIALEXTERNAL FIXATION SYS.	Dec 10, 1980	Substantially Equivalent	Cintor Orthopaedic Div.
K802776	HOFFMAN LEG LENGTHENING DEVICE	Nov 19, 1980	Substantially Equivalent	Howmedica Corp.
K802723	EXTENDED BALLJOINT GRIP	Nov 19, 1980	Substantially Equivalent	Howmedica Corp.
K802722	EXTERNAL FIXATION SYSTEM	Nov 19, 1980	Substantially Equivalent	Howmedica Corp.
K800184	OXFORD EXTERNAL FIXATION SYSTEM	Feb 11, 1980	Substantially Equivalent	Downs Surgical , Ltd.
K792561	MINI-H-FIXATION	Dec 19, 1979	Substantially Equivalent	Geny Medical, Inc.
K791466	ACE EXTERNAL BONE CLAMP PART #S11	Aug 16, 1979	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K790262	UNIVERSAL EXTERNAL FIXATION ASSEMBLY	Feb 13, 1979	Substantially Equivalent	Zimmer, Inc.
K781841	BAR, DISTRACTION	Nov 08, 1978	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K781840	EXTERNAL ARTICULATION	Nov 08, 1978	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K781839	BONE CLAMP, ACE EXTERNAL	Nov 08, 1978	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K781793	FRAME, UNIVERSAL DAY	Nov 03, 1978	Substantially Equivalent	B.G. Orthopedic Corp.
K770066	TIBIAL COMPRESSION FRAM FOR FRACTURES	Mar 30, 1977	Substantially Equivalent	Richard F. Kronner, M.D.
K770388	FRACTURE REDUCTION SYS., MODEL OR 1001	Mar 14, 1977	Substantially Equivalent	Sisan Assoc.
K761088	DEPUY MODIFIED SKELETAL TRACTION PIN	Dec 17, 1976	Substantially Equivalent	Depuy, Inc.