Product Code: LXT FDA class 2 21 CFR 888.3030

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Orthopedic

The Multiple Component Metal Composite Nail/Blade/Plate Combination Fixation Appliance (product code LXT) is an orthopedic implant system combining nails, blades, and plates in a multi-component metal construct used to internally fix complex fractures, particularly of the hip and femur region. Regulated under 21 CFR 888.3030 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Orthopedic specialty. It is not life-sustaining.

View on FDA

510(k)s

FEI Numbers

101

Registration Numbers

101

Unique Applicants

Years Active

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Basic Information

Product Code: LXT
Device Class: FDA class 2
Regulation Number: 888.3030
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 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230067	Para-Fix External Fixation System	Sep 22, 2023	Substantially Equivalent	New Paradigm Biomedical
K131636	POLARUS CONNECT	Oct 10, 2013	Substantially Equivalent	Acumed, LLC
K132704	DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW	Oct 09, 2013	Substantially Equivalent	Biomet
K112345	DISTAL VOLAR RADIUS PLATING SYSTEMS	Oct 31, 2011	Substantially Equivalent	Medos International SARL
K090374	STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S	Mar 11, 2009	Substantially Equivalent	DePuy Orthopaedics, Inc.
K073135	SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS	Jan 29, 2008	Substantially Equivalent	Synthes (Usa)
K063832	SYNTHES (USA) ELBOW HINGE FIXATOR	Mar 07, 2007	Substantially Equivalent	Synthes (Usa)
K060864	MULTIDIRECTIONAL THREADED PEG	Apr 28, 2006	Substantially Equivalent	Hand Innovations, LLC
K060403	PTA (PROGRESSIVE TIBIAL ALIGNMENT)	Mar 28, 2006	Substantially Equivalent	Meridian Medical
K060290	SHOULDER FIXATION SYSTEM	Feb 27, 2006	Substantially Equivalent	Hand Innovations, LLC
K052754	WRIST FUSION PLATE	Oct 27, 2005	Substantially Equivalent	Dvo Extremity Solutions, LLC
K051728	MODIFICATION TO SHOULDER FIXATION SYSTEM	Jul 20, 2005	Substantially Equivalent	Hand Innovations, LLC
K051306	HOFFMANN II MRI EXTERNAL FIXATION SYSTEM	Jun 17, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K050932	DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM	Apr 26, 2005	Substantially Equivalent	Hand Innovations, Inc.
K050631	SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION	Apr 11, 2005	Substantially Equivalent	Synthes (Usa)
K042458	A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM	Oct 07, 2004	Substantially Equivalent	A.M. Surgical, Inc.
K042059	SHOULDER FIXATION SYSTEM	Sep 30, 2004	Substantially Equivalent	Hand Innovations, Inc.
K033805	SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES	Feb 20, 2004	Substantially Equivalent	Synthes (Usa)
K033145	HOFFMANN II PELVIC CLAMP	Nov 05, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032705	DISTAL RADIUS FRACTURE REPAIR SYSTEM	Oct 01, 2003	Substantially Equivalent	Hand Innovations, Inc.
K032169	CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)	Sep 22, 2003	Substantially Equivalent	Cyberorthology, Inc.
K031973	SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE	Sep 05, 2003	Substantially Equivalent	Synthes (Usa)
K031428	SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE	Aug 08, 2003	Substantially Equivalent	Synthes (Usa)
K031959	STRYKER PLATING SYSTEM PERIARTICULAR PLATES	Jul 25, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K030390	SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE	Apr 01, 2003	Substantially Equivalent	Synthes (Usa)
K022651	HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT	Oct 17, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K020905	NBX - NON-BRIDGING EXTERNAL FIXATOR	Apr 15, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K013739	MODIFICATION TO EBI XFIX DFS SYSTEM	Dec 13, 2001	Substantially Equivalent	Ebi, L.P.
K013772	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	Dec 03, 2001	Substantially Equivalent	Howmedica Osteonics
K011948	HOFFMAN II HYBRID RING CLAMP	Jul 13, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K003240	BIOMET EXTERNAL WRIST PLATE	Dec 29, 2000	Substantially Equivalent	Biomet, Inc.
K002923	DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM	Dec 18, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K003211	HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING	Dec 15, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K003205	TRANSFX ANGLED RODS	Dec 15, 2000	Substantially Equivalent	Immedica, Inc.
K001760	RADIOLUCENT COLLES FRACTURE KIT	Aug 31, 2000	Substantially Equivalent	Biomet, Inc.
K001793	SYNTHES SCALLOPED DISTAL TIBIA PLATE	Aug 17, 2000	Substantially Equivalent	Synthes (Usa)
K000972	SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS	Jun 16, 2000	Substantially Equivalent	Synthes (Usa)
K001084	TRANS FX ADJUSTABLE PIN TO BAR CLAMP	Jun 15, 2000	Substantially Equivalent	Immedica, Inc.
K000957	HOFFMANN II EXTERNAL FIXATION SYSTEM	May 23, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K000558	SYNTHES (USA) WRIST FUSION PLATES (WFP)	Apr 14, 2000	Substantially Equivalent	Synthes (Usa)
K991889	ULTIMAX HAIG II NAIL SYSTEM	Aug 12, 1999	Substantially Equivalent	Encore Orthopedics, Inc.
K991723	TRANSFX MULTI PIN CLAMP	Jul 22, 1999	Substantially Equivalent	Immedica, Inc.
K991407	SYNTHES LOCKING CALCANEAL PLATES	Jun 11, 1999	Substantially Equivalent	Synthes (Usa)
K990848	TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION	May 17, 1999	Substantially Equivalent	Immedica, Inc.
K984357	TRANSFX EXTERNAL FIXATION SYSTEM	Mar 04, 1999	Substantially Equivalent	Immedica, Inc.
K974245	DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI	May 22, 1998	Substantially Equivalent	Depuy Ace Medical Co.
K963432	GUIDE WIRES FOR CANNULATED SCREWS	Nov 13, 1996	Substantially Equivalent	Orthopaedic Biosystems, Ltd.
K963618	SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)	Nov 12, 1996	Substantially Equivalent	Synthes (Usa)
K962846	EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM	Oct 23, 1996	Substantially Equivalent	Biodynamic Technologies, Inc.
K954053	BERLIN EXTERNAL FIXATOR	May 16, 1996	Substantially Equivalent	Encore Orthopedics, Inc.
K960269	TITANIUM UNIVERSAL CLAMP	Apr 04, 1996	Substantially Equivalent	Synthes (Usa)
K955388	ACE-DUPONT COMPOSITE RINGS	Jan 31, 1996	Substantially Equivalent	Ace Medical Co.
K953397	HEX-FIX FIELD FIXATOR	Oct 31, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950384	SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR	May 22, 1995	Substantially Equivalent	Synthes (Usa)
K941048	TRUE/LOK MONOLATERAL/BILATERAL FIXATOR	Oct 03, 1994	Substantially Equivalent	Applied Osteo Systems, Inc.
K874377	ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY	May 20, 1988	Substantially Equivalent	Harrington Arthritis Research Center
K864403	MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM	Dec 18, 1986	Substantially Equivalent	Howmedica Corp.