BEUDAMED
    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: JDK FDA class 2

    Prosthesis, Hip, Cement Restrictor

    General, Plastic Surgery

    View full classification →

    A hip prosthesis cement restrictor is an implantable plug placed within the femoral canal to prevent bone cement from migrating distally during hip arthroplasty, ensuring adequate cement pressurization and optimal interdigitation with the surrounding cancellous bone. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JDK, regulated under 21 CFR 878.3300, within the General and Plastic Surgery medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Mectaplug PE II
    KMI CEMENT RESTRICTOR IMPLANT
    MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
    LIFE SPINE CEMENT RESTRICTOR
    SPINAL USA CEMENT RESTRICTOR SYSTEM
    INTERBODY INNOVATIONS CEMENT RESTRICTOR
    SKELITE RESORBABLE CEMENT RESTRICTOR
    NOVASPINE CEMENT RESTRICTOR NSCR
    SCIENT'X CEMENT RESTRICTOR
    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
    PEEK CEMENT RESTRICTOR X-BOX
    OPTIMESH 500E CEMENT RESTRICTOR
    QUANTUM CEMENT RESTRICTOR
    FIDJI LARGE CEMENT RESTRICTOR
    FIDJI SMALL CEMENT RESTRICTOR
    THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
    NUVASIVE CEMENT RESTRICTOR
    TRAXIS CEMENT RESTRICTOR
    INTERPORE CROSS CEMENT RESTRICTOR
    MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
    OTI BONE CEMENT PLUG
    INTERPORE CROSS CEMENT RESTRICTOR
    CADENCE PEEK CEMEENT RESTRICTOR
    CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
    NBD CEMENT RESTRICTOR DEVICE
    CEMENT RESTRICTOR, SMALL AND LARGE
    FORTITUDE CEMENT RESTRICTOR
    CADENCE CEMENT RESTRICTOR
    RABEA CEMENT RESTRICTOR
    RPX TITANIUM CEMNT RESTRICTOR
    CEMENT RESTRICTOR
    THEKEN LARGE CEMENT RESTRICTOR
    THEKEN SMALL CEMENT RESTRICTOR
    TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
    BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
    THREADED CEMENT RESTRICTOR (CR) TITANIUM
    MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
    METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
    TITANIUM CEMENT RESTRICTOR (TCR)
    RABEA DEVICE, MODEL PXXXXXX
    OSTEONICS SCREW HOLE PLUGS
    BONE CEMENT RESTRICTOR
    OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
    LIMA CEMENT RESTRICTOR
    OSTEONICS(R) MID-SHAFT CEMENT SPACER
    S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
    OSTEONICS CEMENT RESTRICTOR
    PROXIMAL CEMENT SPACER
    PT DISTAL TIP CEMENT SPACER

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump