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510(k) Data Aggregation

    K Number
    K241260
    Device Name
    ACTIFY™ Unicondylar Knee System
    Manufacturer
    Globus Medical, Inc
    Date Cleared
    2024-12-06

    (214 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K122883,K162222,K032824,K033363,K230653,K071881,K203099
    Why did this record match?
    Reference Devices :

    K122883, K162222

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

    The ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions:

    1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis.
    2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
    3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
    4. Previous tibial condyle or plateau fractures with loss of anatomy or function.
    5. Varus or valgus deformities.
      These devices are indicated for cemented use only.
    Device Description

    The ACTIFY™ Unicondylar Knee System implants consist of femoral and tibial implants that are used as part of a unicompartmental knee system for partial knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. ACTIFY Unicondylar femoral implants are manufactured from cobalt chrome alloy, tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) with and without Vitamin E, and tibia trays are manufactured from titanium alloy.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification for a medical device (ACTIFY™ Unicondylar Knee System) and does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.

    The document discusses:

    • The FDA's decision of substantial equivalence to predicate devices.
    • The indications for use of the device.
    • The materials and components of the device.
    • A list of performance tests conducted (fatigue, wear, interlocking strength, etc.) according to various ASTM and ISO standards.
    • A general statement that "Performance data demonstrate substantial equivalence to the predicate devices."

    It does not provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any clinical or large-scale performance study.
    3. Information on experts, adjudication methods, or ground truth for a test set.
    4. Details on MRMC studies or AI assistance.
    5. Information about standalone algorithm performance.
    6. Sample sizes or ground truth establishment for a training set.

    Therefore, I cannot fulfill your request based on the provided text.

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