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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: LZO FDA class 2

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    Orthopedic

    View full classification →

    The Cemented or Non-Porous Uncemented Semi-Constrained Metal/Ceramic/Polymer Hip Prosthesis (product code LZO) is an orthopedic implant used to replace the hip joint using a metal, ceramic, and polymer composite construct available in cemented or non-porous uncemented configurations. Regulated under 21 CFR 888.3353 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Orthopedic specialty. It is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RECLAIM Monobloc Revision Femoral Stem
    MobileLink Acetabular Cup System - inhouse coatings
    NEXUS® Hip Stem
    Origin™ Cemented Hip Stem
    Zimmer Biomet Ceramic Heads (22.2mm diameter)
    CATALYSTEM Femoral Stems
    Origin™ TT Stem
    Versacem Acetabular Shell and Double Mobility HC Liners
    Biolox® Delta Revision heads
    ceramys™ femoral head system
    Conformity Stem Extension Line, #0
    BIOCERAM AZUL® HEAD
    b-ONE® Total Hip System
    MUTARS® femoral stem cemented 160 mm and 200 mm
    Conformity Stem Extension Line
    Z1 Cemented Hip System
    CATALYSTEM Femoral Stems
    EcoFit® short stem cementless cpTi
    22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
    Ceramic Femoral Head
    28mm/38D MDM X3 Insert for MDM Liner
    Z1 Hip System
    Novae® Dual Mobility System, Hype® Hip System
    Actinia® hip stems
    EMPHASYS Femoral Stems
    MINIMA S System
    BethaLoc® stem cementless HA
    Xerxes Hip Stem
    Exactech® Alteon® Short Tapered Wedge
    BENCOX Delta Option Heads
    ARTICUL/EZE Ceramic Heads
    U-Motion II Acetabular System-Extension line
    DePuy Reclaim Monobloc Revision Femoral Stem
    Platform® Acetabular System
    SP-CL Hip Stem and LCU Hip System
    implaFit® hip stems
    DM Converter - TiN coated
    BiMobile Instruments (for BiMobile Dual Mobility System)
    M-Vizion Monobloc
    Amis K Long
    MP Reconstruction System
    Corin MetaFix™ Hip Stem
    DePuy Corail AMT Hip Prosthesis
    Restoration Modular 115mm Conical Distal Stem
    Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
    Mpres Neck Preserving Stem
    EMPHASYS Femoral Stems
    Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
    POLARSTEM Cemented Femoral Stem
    POLARSTEM Calcar Reamer Guide

    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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