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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: HRY FDA class 2

    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

    Orthopedic

    View full classification →

    A femorotibial knee prosthesis of the semi-constrained, cemented, metal/polymer type is a total or partial knee replacement implant used to resurface and replace the articulating surfaces of the femur and tibia when damaged by disease or injury. It is classified as an FDA Class 2 device under 21 CFR 888.3530, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRY falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SIGMA High Performance (HP) Partial Knee System
    NanoOrtho NanoKnee® System
    MPO Total Knee Systems MR Labeling
    RESTORIS POROUS PARTIAL KNEE SYSTEM
    OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
    UNIVATION
    OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
    SIGNATURE PLANNER / SIGNATURE GUIDES
    EVOLUTION UNICONDYLAR KNEE SYSTEM
    STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
    UNIVATION UNICONDYLAR KNEE SYSTEM
    UNICOMPARTMENTAL KNEE
    TRIATHLON PKR SYSTEM
    DEPUY GCK TIBIAL COMPONENTS
    TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
    REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
    ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
    REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
    GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
    UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
    VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
    EXACTECH OPTETRAK UNICONDYLAR KNEE
    DEPUY PRESERVATION UNICONDYLAR TIBIA
    GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
    NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
    UC-PLUS SOLUTION UNICONDYLAR KNEE
    REPICCI LOCKED KEEL TIBIAL BEARING
    ADVANCE LESS CONFORMING TIBIAL COMPONENT
    UNI KNEE
    FIXED BEARING UNI COMPONENT
    UNICONDYLAR KNEE
    SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
    ADVANCE UNICONDYLAR KNEE SYSTEM
    REPICCI II UNICONDYLAR KNEE SYSTEM
    MJS POSTERIOR STABILIZED KNEE SYSTEM
    ADVANCE UNICONDYLAR KNEE SYSTEM
    OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
    BARRETT UNICONDYLAR TIBIAL BEARING
    WORLAND UNICONDYLAR TIBIAL BEARING
    DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
    MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
    OSTEONICS SERIES 7000 AD TIBIAL TRAY
    DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
    UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
    REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
    OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
    REPICCI II UNICONDYLAR KNEE
    P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
    TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
    ADVANCE TIBIAL COMPONENT

    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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