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510(k) Data Aggregation

    K Number
    K032905
    Device Name
    3DKNEE POROUS COATED FEMORAL COMPONENT
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Date Cleared
    2004-07-06

    (293 days)

    Product Code
    MBH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K020114
    Why did this record match?
    Device Name :

    3DKNEE POROUS COATED FEMORAL COMPONENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
    Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
    Avascular necrosis of the femoral condyle
    Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
    Moderate valgus, varus or flexion deformities
    Rheumatoid arthritis
    Treatment of fractures that are unmanageable using other techniques.

    Device Description

    The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) submission summary for a knee implant device (3DKnee™ Porous Coated Femoral Component). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as it pertains to AI/algorithm-based medical devices or comparative effectiveness studies.

    The document is for a physical medical device (a knee implant) and focuses on describing the device, its indications for use, and its substantial equivalence to a previously cleared device (K020114) based on design, materials, and indications, rather than clinical performance data from a study with acceptance criteria.

    Therefore, I cannot fulfill your request for an acceptance criteria table and information about a study proving the device meets those criteria, as that information is not present in the provided text.

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