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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: MBH FDA class 2

    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    Orthopedic

    View full classification →

    The semi-constrained uncemented porous coated polymer/metal/polymer patello/femorotibial knee prosthesis is an orthopedic implant used to resurface the knee joint in patients with degenerative joint disease, relying on porous coating for osseointegration without bone cement. It is classified as FDA Class II under 21 CFR 888.3565 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBH and it carries an implant flag reflecting its permanent surgical placement. Full GMP compliance is required.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Physica System (Physica CR Porous Femoral components)
    iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
    Freedom® Total Knee System - Porous Tibial Base Plate
    Zimmer® Persona® Personalized Knee System
    Physica Porous Femoral Components
    Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
    Agility Symmetric™ Total Knee System
    Persona the Personalized Knee System
    Exactech® TRULIANT® Knee System
    The Optimotion™ Blue Plus Knee System
    ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
    Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
    EVOLUTION® Tibial Cones
    ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
    Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
    Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
    ATTUNE® Revision Cones
    U2 Total Knee System-PF+
    GMK Sphere & GMK SpheriKA Cementless
    Zimmer Persona Personalized Knee System
    ATTUNE Revision Cones
    GMK 3D Metal Tibial Tray
    Optimotion Implants Porous Metal-Backed Patella
    Porous Patella
    ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
    MPO Knee Instruments; MPO PROPHECY Knee Instruments
    Porous Patella and Porous Tibia Baseplate
    Symmetric Total Knee System
    LEGION CR Porous Plus HA Femoral Components
    Physica system
    EMPOWR Porous Femur with HAnano SurfaceTM
    LEGION Porous CR Narrow Femoral Components
    Physica system
    ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
    UNIKO PointCloud™ Knee Instruments
    LINK TrabecuLink Femoral Cones
    Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
    The Optimotion Blue Total Knee System
    LINK TrabecuLink Tibial Cones
    Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
    TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
    Truliant Porous Femoral Components
    Zimmer Persona Personalized Knee System
    EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
    Triathlon Total Knee System
    Zimmer Persona Personalized Knee System
    Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
    Arthrex Knee Systems
    EMPOWR Porous Knee System
    BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

    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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