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    K Number
    K042030
    Device Name
    HYPROCURE SUBTALAR IMPLANT SYSTEM
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
    Date Cleared
    2004-09-16

    (50 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYPROCURE SUBTALAR IMPLANT SYSTEM

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

    The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment methods, expert qualifications, or adjudication methods for a medical device.

    The document is a 510(k) clearance letter from the FDA for a device called "HyProCure Subtalar Implant System." It states that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use, but does not include any performance data, study details, or acceptance criteria.

    Without this information, I cannot fulfill your request.

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