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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LXT FDA class 2

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

    Orthopedic

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Para-Fix External Fixation System
    POLARUS CONNECT
    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
    DISTAL VOLAR RADIUS PLATING SYSTEMS
    STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
    SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
    SYNTHES (USA) ELBOW HINGE FIXATOR
    MULTIDIRECTIONAL THREADED PEG
    PTA (PROGRESSIVE TIBIAL ALIGNMENT)
    SHOULDER FIXATION SYSTEM
    WRIST FUSION PLATE
    MODIFICATION TO SHOULDER FIXATION SYSTEM
    HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
    DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
    SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
    A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
    SHOULDER FIXATION SYSTEM
    SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
    HOFFMANN II PELVIC CLAMP
    DISTAL RADIUS FRACTURE REPAIR SYSTEM
    CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
    SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
    SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
    STRYKER PLATING SYSTEM PERIARTICULAR PLATES
    SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
    HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
    NBX - NON-BRIDGING EXTERNAL FIXATOR
    MODIFICATION TO EBI XFIX DFS SYSTEM
    MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
    HOFFMAN II HYBRID RING CLAMP
    BIOMET EXTERNAL WRIST PLATE
    DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
    HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
    TRANSFX ANGLED RODS
    RADIOLUCENT COLLES FRACTURE KIT
    SYNTHES SCALLOPED DISTAL TIBIA PLATE
    SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
    TRANS FX ADJUSTABLE PIN TO BAR CLAMP
    HOFFMANN II EXTERNAL FIXATION SYSTEM
    SYNTHES (USA) WRIST FUSION PLATES (WFP)
    ULTIMAX HAIG II NAIL SYSTEM
    TRANSFX MULTI PIN CLAMP
    SYNTHES LOCKING CALCANEAL PLATES
    TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
    TRANSFX EXTERNAL FIXATION SYSTEM
    DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
    GUIDE WIRES FOR CANNULATED SCREWS
    SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
    EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
    BERLIN EXTERNAL FIXATOR

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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