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510(k) Data Aggregation

    K Number
    K213793
    Device Name
    EMPOWR Revision Knee
    Manufacturer
    Encore Medical, L.P.
    Date Cleared
    2022-04-01

    (116 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K160342,K173723,K140830
    Why did this record match?
    Reference Devices :

    K160342, K173723, K140830

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

    Joint replacement is indicated for patients suffering from disability due to:

    · degenerative, post-traumatic or rheumatoid 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;

    · treatment of fractures that are unmanageable using other techniques.

    This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia which are intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

    Device Description

    EMPOWR Revision Knee™ is intended for total knee prosthesis. The system consists of the sterile implants; EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal. Non-sterile reusable instruments and trials are included as accessories.

    The femur component can optionally be used with a stem extender and/or augments to suit a variety of surgeon preferences and patient anatomies.

    AI/ML Overview

    This FDA 510(k) submission for the EMPOWR Revision Knee™ does not involve an AI/ML device. It is for a traditional medical device, specifically a knee replacement prosthesis.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details in the context of AI/ML is not applicable to this document.

    The document describes material and mechanical performance testing for the knee prosthesis against recognized FDA standards and internal protocols to demonstrate substantial equivalence to predicate devices, as specified in Section VII (Performance Testing) on page 4. However, these are not AI/ML performance metrics.

    In summary, the provided document does not contain information about an AI/ML device, its acceptance criteria, or the studies proving it meets those criteria.

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