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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: LXH FDA class 1

    Orthopedic Manual Surgical Instrument

    Orthopedic

    View full classification →

    The Orthopedic Manual Surgical Instrument (product code LXH) encompasses hand-held, non-powered tools used during orthopedic surgical procedures, such as chisels, osteotomes, curettes, and other manual instruments that do not apply significant energy to the patient. Regulated under 21 CFR 888.4540 and classified as a Class 1 device, it is subject only to general controls and falls under the Orthopedic medical specialty. The device is not an implant, is not life-sustaining, and is not GMP-exempt.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SX-One MicroKnife
    IMBIBE NEEDLE
    SELF RETAINING SOFT TISSUE RETRACTOR
    MICROPERFORATION INSTRUMENT
    ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
    ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
    SPINAL MARKER
    STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
    HYPERFLEX FLEXIBLE GUIDEWIRES
    STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
    PUNCH SURGICAL
    SOFAMOR ORTHOPAEDIC INSTRUMENTS
    BARRIER BONE WAX APPLICATOR
    BIO-PREP
    CALMPS: BONE, MASTIN, LEWIN, BRAND
    SURGICAL INSTRUMENT, DISPOSABLE
    AMSEN HOCKEY STICK CHISEL
    AMSEN POSTERIOR DISC EVACUATOR
    AMSEN DOUBLE-ENDED FORAMINAL PROBE
    AMSEN SPINE IMPACTOR INSTRUMENTS
    VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
    OSTEOTOMES OF VARIOUS TYPES
    RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
    CHISEL, BONE, SURGICAL
    LAMINECTOMY ROGEUR
    T-HANDLE HEX WRENCH
    ADJUSTABLE ANGLE GUIDE
    DRIVER/EXTRACTOR
    KRONNER SACRAL PIN GUIDE
    COHN TARGETEER
    RETRACTORS
    RETRACTOR, SELF-RETAINING
    GOUGES FOR FEMORAL HEADS
    THOMPSON TYPE RASP W/TOMMY BAR
    HUDSON BRACE W/BURRS
    IMPACTOR FOR FEMORAL HEAD
    RONGUER-ORTHOPEDIC
    EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD
    FORCEPS
    AUSTIN MOORE HALLOW CHISEL
    TENSIOMETER
    SPINAL DISTRACTORS, SPANNERS
    MICRODISCECTOMY CURRETTES
    PATELLAR TENDON GRAFT GUIDE
    ACROMED SPINAL SURGERY INSTRUMENTS
    ORTHOPEDIC CUSTOM SURGICAL KIT
    HENNING MENISCAL SUTURE KIT
    6.5MM HEX HANDLE
    CAMELBACK HANDLE-K841969-LABELING
    NEEDLE BENDER TX8225

    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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