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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: KWL FDA class 2

    Prosthesis, Hip, Hemi-, Femoral, Metal

    Orthopedic

    View full classification →

    The Metal Femoral Hemi Hip Prosthesis is an orthopedic implant used to replace the femoral head and neck of the hip joint with a metal component, applied in cases of femoral neck fractures or isolated femoral head disease where the acetabulum remains intact. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWL, regulated under 21 CFR 888.3360, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
    COPAL® exchange G hip spacer; COPAL® G+V
    UHR Bipolar Implants, Restoration GAP II Implants
    OsteoRemedies Hip Spacer System
    REMEDY Acetabular Cup
    REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
    Remedy Acetabular Cup
    Evolve UniPolar Head
    2GC HIP/KNEE MODULAR SPACER
    Spacer-G and Spacer-K
    CORIN OPTIMOM MODULAR HEAD
    SPACER-G TEMPORARY HIP PROSTHESIS
    CORIN ADAPTOR SLEEVE
    CORIN UNIPOLAR MODULAR HEAD
    SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
    SMITH & NEPHEW MODULAR FEMORAL HEAD
    SOLITUDE UNIPOLAR HEAD
    SPACER G TEMPORARY HIP PROSTHESIS
    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
    CONSENSUS UNIPOLAR HEAD, COCR
    UNITRAX MODULAR UNIPOLAR SYSTEM
    UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
    PLUS FRACTURE HEAD PROSTHESIS
    OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
    THE NEW BIO-MOORE ENDO HEADS
    ARGOMEDICAL BIPOLAR SYSTEM
    OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
    FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
    ULTIMA TPS CEMENTED STEM
    ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
    PRIME MODULAR ENDO HEAD
    OPTEON UNIPOLAR
    JOHNSON & JOHNSON AUSTIN MOORE STEM
    OSTEONICS UNIPOLAR ENDO HEAD
    UNITRAX V40 MODULAR ADAPTOR
    OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
    ULTIMA AUGMENTED UHMWPE CUP
    LINK SADDLE PROTHESIS
    CORIN THOMPSON PROSTHESIS, MODIFICATION
    CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
    ULTIMA UNIPOLAR MODULAR HEAD
    ZIRCONIUM ALLOY UNI-POLAR HEAD
    TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
    CONTOUR FEMORAL HIP STEM WITH POROCOAT
    ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
    OSTRONCS HEMI-HIP STEM SERIES
    OMNIFIT M-HA HIP STEM SERIES
    OMNIFLEX M-HA HIP STEM SERIES
    PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
    MTS FEMORAL HIP SYSTEM

    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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