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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: KRO FDA class 2

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

    Orthopedic

    View full classification →

    This device is a constrained cemented femorotibial knee prosthesis made from metal and polymer, used in total knee replacement surgery for patients who require a higher degree of mechanical constraint due to ligament insufficiency or severe joint deformity. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRO, regulated under 21 CFR 888.3510 within the Orthopedic specialty. This device is designated as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ATTUNE™ Revision Hinge Knee
    EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
    ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
    EVOLUTION® Hinge Knee System
    Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
    Modular Rotating Hinge Knee Systems and Compatible Components
    Triathlon® Hinge Knee System
    LINK Endo-Model EVO Knee System
    ELEOS Limb Salvage System
    LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
    GMK Revision & Hinge Extension - TiNbN Coating
    Zimmer Segmental System
    Instruments for LINK MEGASYSTEM-C Family
    Attune Revision LPS Inserts
    USTAR II System
    GMK Hinge, GMK Revision
    GMK Revision Femoral Distal Augmentation
    ELEOS Limb Salvage System
    LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
    LINK® MEGASYSTEM-C®
    Smith and Nephew Legion Hinge Knee System
    PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
    Zimmer Segmental System XT Components
    The LINK® Endo-Model® Knee System
    PATIENT SPECIFIC DISTAL FEMORAL
    BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
    MAK OSS FEMORAL KNEE COMPONENTS
    GMK HINGE
    DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
    METS MODULAR DISTAL FEMUR
    METS SMILES TOTAL KNEE REPLACEMENT
    ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
    JTS EXTENDEABLE IMPLANT
    ENDURO KNEE SYSTEM
    LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
    MAK OSS KNEE FEMORAL COMPONENTS
    ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
    LEGION HINGE KNEE SYSTEM
    SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
    REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
    ZIMMER SEGMENTAL SYSTEM
    DEPUY LPS PROXIMAL TIBIAL COMPONENT
    HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
    OSS-BODIES PROXIMAL TIBIAL SLEEVE
    ORTHOPEDIC SALVAGE SYSTEM- OSS
    RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
    AVL HINGE KNEE SYSTEM
    COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
    MODULAR REPLACEMENT SYSTEM CEMENTED STEMS

    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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