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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: JDG FDA class 2

    Prosthesis, Hip, Femoral Component, Cemented, Metal

    Orthopedic

    View full classification →

    A metal cemented femoral component hip prosthesis is an implantable orthopedic device that replaces the femoral head and neck and is fixed within the femoral canal using bone cement, used in total or hemi hip arthroplasty to restore hip joint function in patients with degenerative or traumatic hip disease. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDG, regulated under 21 CFR 888.3360, within the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
    Distal Centralizers
    Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
    PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
    THE TAPER-FIT TOTAL HIP SYSTEM
    AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
    NEXLOCK FEMORAL STEM
    LUBINUS SP II HIP SYSTEM
    HIP FRACTURE STEM FENESTRATION PLUG
    ORTHOMET TITANIUM HYBRID FEMORAL STEM
    PROFORM CEMENTED FEMORAL COMPONENT
    INTEGRAL CO-CR FEMORAL COMPONENT
    IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
    RX90 FEMORAL COMPONENT
    CO-CR ANSWER FEMORAL COMPONENT
    S-ROM TOTAL HIP REPLACEMENT SYSTEM
    BRIDGE(TM) HIP SYSTEM
    PPC HIP STEM COMPONENT
    FPC HIP STEM COMPONENT
    UFC HIP STEM COMPONENT
    STABILITY HIP STEM WITH POROCOAT
    AMERICANA HIP PROTHESIS
    INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
    OPTI-FIX COLLARED FEMORAL COMPONENTS
    PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
    AML CALCAR FEMORAL PROSTHESIS
    CTI STRAIGHT STEM
    WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
    THOMPSON HIP PROSTHESIS
    HOWMEDICA PCA COLLARED FEMORAL STEM
    PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
    HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
    BDH UNIVERSAL HIP SYSTEM SURGEON
    SEATTLE II TOTAL HIP SYSTEM
    BRIGHAM II TOTAL HIP SYSTEM
    CHARNLEY DESIGN HIP PROSTHESIS
    HEXCEL FEMORAL COMPONENT HIP PROSTHESIS
    ANITOMIC TOTAL HIP SYSTEM
    BIOPHASE IMPLANT MATERIAL
    PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
    SPHERISTEM TOTAL HIP PROSTHESIS
    TITANIUM MULLER TOTAL HIP
    TOTAL HIP, NEW ENGLAND BAPTIST
    TOTAL HIP, CHARNELY TYPE
    KERBOULL-CHARNLEY CUP SPECIAL MODEL
    LAGRANGE LETOURNEL TOTAL HIP FEMORAL
    WATSON-FARRAR TOTAL HIP REPLACEMENT
    BI-CENTRIC ENDOPROSTHESES
    MICROFENESTRATED HIP REPLACEMENT COMPON.
    12-9170 SERIES II TOTAL HIP

    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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