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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: JDI FDA class 2

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

    Orthopedic

    View full classification →

    A semi-constrained metal and polymer cemented hip prosthesis is a total hip replacement implant that uses a cemented fixation technique to anchor metal femoral and polymer acetabular components, providing controlled constraint to the articulation and used in patients with end-stage hip arthritis or other joint destructive conditions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDI, regulated under 21 CFR 888.3350, within the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
    Stryker Orthopaedics Hip Systems Labeling Update
    Global Modular Replacement System
    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
    C-Stem AMT LE Prosthesis
    Exeter® X3® RimFit® Cup
    MPO Hip Instruments
    VerSys Cemented Revision/Calcar
    ELEOS Limb Salvage System with BioGrip
    ELEOS™ Limb Salvage System
    ELEOS Limb Salvage System featuring BIOGRIP
    PROFEMUR® GLADIATOR® Cemented Classic Stem
    Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
    ZCA All-Poly Acetabular Cups
    Zimmer, Inc. Hip Joint Prostheses MR Labeling I
    CPT Hip System
    Conformity stem, cemented
    EXETER Centralizer, EXETER 2.5mm Plug
    Cemented TSI Hip Stem
    Libertas Hip Replacement System
    MALUC™ Total Hip Arthroplasty System
    REDAPT Anteverted Cemented Liner
    FitRite™ Total Hip Arthroplasty System
    Corin TaperFit Hip Stem
    Alpine Cemented Hip System
    OSS/Arcos IM Total Femur Rod
    Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
    Corin TaperFit Hip Stem
    BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
    Sirius Femoral Stem, Size 30A
    RENOVIS CEMENTED HIP SYSTEM
    SIRIUS FEMORAL STEM
    SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
    OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
    METS MODULAR PROXIMAL FEMUR
    METS MODULAR TOTAL FEMUR
    SIGNATURE PLANNER,SIGNATURE GUIDES
    ACCOLADE II HIP STEM
    EXETER X3 RIMFIT ACETABULAR CUP
    EXETER HIP STEM
    DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
    DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
    BIOPRO FEMORAL HEADS
    MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
    DEPUY C-STEM AMT
    ACCIN UNIPOLAR HEAD SYSTEM
    MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
    TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
    100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

    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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