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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: MEH FDA class 2

    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

    Orthopedic

    View full classification →

    The semi-constrained uncemented non-porous calcium phosphate-coated metal/polymer hip prosthesis is an orthopedic implant used to replace the hip joint, utilizing a calcium phosphate surface treatment to promote bone bonding without the use of bone cement. It is classified as FDA Class II under 21 CFR 888.3353 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MEH and it carries an implant flag. Full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Mfinity Femoral System
    Trivicta® Hip Stem
    Resolve Modular Revision Hip Stem
    Alteon® HA Femoral Stems
    World Liner
    Icona Hip Stem
    TheRay Collared and Collarless Femoral Stem
    Logical Liner; World Liner; World Knee Patella
    Trivicta™ Hip Stem
    DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
    ACTERA™ hip system
    SignaSure Dual Mobility System
    Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
    Actera™ hip system
    SignaSure Dual Mobility System
    Encore Hip Stem
    Insignia Hip Stem
    Actis DuoFix Hip Prosthesis- Collarless
    MUTARS Cemented Femoral Stems
    World Hip Stem, World Cup, World Liner
    Summit DuoFix HA Coating
    MUTARS Proximal Femur Replacement System
    Corin TriFit CF Hip Stem
    LINK® BiMobile(TM) Dual Mobility System
    Entrada™ hip stem
    REDAPT Sleeved Monolithic Revision Stems
    Exactech® Alteon® HA Femoral Stem
    Exactech® Novation® Element Press-fit Femoral Stem
    H-Max S stem
    Origin Coxa Vara Hip Stem
    DePuy Actis DuoFix Hip Prosthesis
    Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
    Corin TriFit TS Hip
    H-MAX S Femoral Hip System
    DePuy Actis Duofox Hip Prosthesis
    NOVEL FIT AND FILL STEM
    H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
    SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
    SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
    CORIN TRIFIT TS HIP
    MODULAR PROXIMALLY FLUTED HIP STEM
    NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
    MSA HIP SYSTEM
    ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
    NOVEL TAPERED HIP STEM
    CERAMIC FEMORAL HEAD
    MSA HIP SYSTEM
    PREVISION HIP SYSTEM WITH RECON RING
    TRINITY ACETABULAR SYSTEM
    SMITH & NEPHEW MDF MODULAR SLEEVE

    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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