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510(k) Data Aggregation

    K Number
    K053543
    Device Name
    ARTHREX ARTHOERESIS IMPLANT
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2006-04-03

    (104 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K960692,K001231,K042030,K031155
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot

    Examples include:

    • Symptomatic acquired flat foot treatment in children and adolescents .
    • Symptomatic congenital flexible flat foot .
    • Tarsal coalitions when associated with a flatfoot deformity .
    • Posterior tibial tendon dysfunction with supple feet .
    • Paralytic flat foot .
    Device Description

    The Arthrex Arthroeresis Family is currently comprised of titanium allov implants according to ASTM F-136. They are offered in several different sizes. They are offered sterile.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) summary for the Arthrex Arthroeresis Family, which outlines the device description, indications for use, and a statement of substantial equivalence to predicate devices. It discusses regulatory classification and general controls but does not include any performance data, study designs, or details regarding acceptance criteria for device performance.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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