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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: KWY FDA class 2

    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

    Orthopedic

    View full classification →

    The Metal/Polymer Cemented or Uncemented Femoral Hemi Hip Prosthesis is an orthopedic implant used to replace the femoral head component of the hip joint using a combined metal and polymer design, accommodating either cemented or press-fit fixation techniques, applied in hemiarthroplasty for hip fracture or femoral head disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWY, regulated under 21 CFR 888.3390, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CORAIL Cemented Femoral Stem
    SpaceFlex Acetabular Cup
    Vario-Cup System
    COPAL exchange G hip spacer
    Kyocera Bipolar Hip System
    Fitmore Hip Stem
    COPAL exchange G Hip and Knee Spacers
    iNSitu Bipolar Hip System
    Implantcast ic-Bipolar Head System
    Corin BiPolar-i
    SurgTech Bipolar Head System
    ELEOS™ Bipolar Acetabular System
    40-42mm BiPolar Head and 22mm Femoral Head
    Fitmore® Hip Stem
    U2 Bipolar Implant and 22mm Femoral Head
    Klassic BiPolar System
    RING-LOK MODULAR BIPOLAR SYSTEM
    RENOVIS BIPOLAR HIP SYSTEM
    DEPUY CORAIL AMT HIP PROSTHESIS
    TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
    BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
    BIOPRO POLAR HEAD
    UNITED U2 BIPOLAR IMPLANT
    APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
    MEDACTA BIPOLAR HEAD
    APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
    BIOPRO BIPOLAR HEAD, MODELS 18130-18152
    STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
    ACCIN BIPOLAR HEAD SYSTEM
    GLADIATOR BIPOLAR SYSTEM
    AESCULAP BIPOLAR ACETABULAR CUP
    STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
    U1 HIP SYSTEM - BIPOLAR
    PIVOT BIPOLAR FEMORAL HEAD
    DURASUL BIPOLAR
    SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
    ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
    M2A 32MM TAPER SYSTEM
    TRI-POLAR SYSTEM
    G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    PLUS BIPOLAR PROSTHESIS COCRMO
    ODC B2 BIPOLAR CUP
    BIPOLAR FEMORAL HEAD
    J-FX BIPOLAR HEAD
    IMPLEX BIPOLAR HIP SYSTEM
    ARTOS, DIPLOS SYSTEM
    ADVANTAGE MAPF HIP FEMORAL COMPONENT
    ULTIMA FX FEMORAL HIP STEMS

    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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