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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: LWJ FDA class 2

    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

    Orthopedic

    View full classification →

    The Uncemented Semi-Constrained Metal/Polymer Hip Prosthesis (product code LWJ) is an orthopedic implant used to replace a damaged or diseased hip joint with a metal and polymer construct that achieves fixation through biological bone ingrowth rather than bone cement. Regulated under 21 CFR 888.3360 and classified as a Class 2 device, it requires a 510(k) premarket notification and is reviewed under the Orthopedic panel. The device is flagged as an implant due to its surgical placement within the body. It is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    UNISYN PLUS HIP STEM
    TRINITY ACETABULAR SYSTEM
    NOVATION CFS PRESS-FIT AND CEMENTED STEMS
    METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
    36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
    U2 HIP STEM, TI PLASMA SPRAY
    UNISYN HA PLASMA MODULAR HIP
    EXCIA
    BETACONE HIP PROSTHESIS SYSTEM
    U2 ACETABULAR COMPONENT
    EXCIA TOTAL HIP SYSTEM
    Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
    QUATRO M FEMORAL COMPONENT
    MODULAR PLUS HIP STEM
    PROCLASS PRESS FIT HIP STEM
    MODIFICATION TO MODULAR PLUS REVISION STEM
    GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
    DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
    UNI HIP STEM
    PROXILOCK HIP PROSTHESIS; SIZE 12/36
    TRITON HIP SYSTEM
    TRI-FIT FEMORAL STEM
    PRO-FEMUR R
    EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
    ACETABULAR PLATES
    INTER-OP DURASUL ACETABULAR INSERTS (4MM)
    MODIFICATION TO PROVIDENT HIP SYSTEM
    ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
    THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
    MODIFICATION TO PROVIDENT HIP SYSTEM
    SL-PLUS AND SLR-PLUS STEMS
    MODULAR-PLUS REVISION STEM
    HOWMEDICA OSTEONICS FEMORAL HEADS
    OSTEONICS EXTENDED FEMORAL BEARING HEAD
    LATERAL FLARE INTERNAL COLLAR (LFIC)
    PLUS EPF ACETABULAR CUP
    PLUS-FIT ACETABULAR CUP
    PRESS-FIT HIP STEM
    PERFECTA REVISION HIP SYSTEM
    SC, CEMENTLESS HIP SYSTEM
    CHROME COBALT BALL HEAD
    DELTA HIP PROSTHESIS
    PRESS-FIT FLARED SHELL
    INTERMOORE FRACTURE HIP STEM (MODIFY)
    SRRS PRESSED FIT FEMORAL REVISION COMPONENT
    INTERMOORE FRACTURE HIP STEM
    LFIC OR FETTO HIP
    DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
    FOUNDATION TEXTURED STEM
    HOWMEDICA V40 22MM FEMORAL HEAD

    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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