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510(k) Data Aggregation

    K Number
    K050764
    Device Name
    UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
    Manufacturer
    CORIN U.S.A.
    Date Cleared
    2005-08-24

    (153 days)

    Product Code
    HRY,CLA
    Regulation Number
    888.3530
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K042093,K980665,K954186,K982859
    Why did this record match?
    Device Name :

    UNIGLIDE UNICONDYLAR KNEE PROSTHESIS

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

    The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.

    Device Description

    The device consists of Cobalt Chrome (CoCr) alloy femoral component which articulates against an ultra high molecular polyethylene (UHMWPE) tibial component.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Uniglide Unicondylar Knee Replacement System) seeking market clearance based on substantial equivalence to existing devices. It does not contain information about acceptance criteria, specific device performance metrics, or study details like sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and detailed study information based solely on the input text. The document focuses on regulatory approval and substantial equivalence rather than a detailed performance study report.

    The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and indications for use, rather than extensive new clinical studies with defined acceptance criteria and performance metrics described in the way you've outlined for AI/diagnostic devices.

    If this were a submission for a diagnostic device applying AI, this kind of information would be essential, but for a mechanical implant like a knee replacement, the focus is different.

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