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510(k) Data Aggregation

    K Number
    K063070
    Device Name
    APERFIX TIBIAL IMPLANT WITH INSERTER
    Manufacturer
    CAYENNE MEDICAL, INC.
    Date Cleared
    2006-12-14

    (69 days)

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

    The AperFix™ Tibial Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.

    Device Description

    The AperFix Tibial Implant is a device that provides soft tissue compression within the prepared tibial tunnel to anchor the tendon. It includes a screw and a two-part screw sheath. AperFix Tibial Implants are available in diameters of 9, 10 and 11 mm with a standard length of 30 mm. Each AperFix Tibial Implant is supplied with the implant screw pre-loaded on a disposable inserter. The role of the inserter is to assist in implant placement within the tibial tunnel.

    The AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.

    AI/ML Overview

    The provided text is a 510(k) summary for the AperFix™ Tibial Implant with Inserter, a medical device for bone fixation. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI/ML device.

    Therefore, I cannot provide the requested information in the specified format because the input utterly lacks the descriptions of acceptance criteria, device performance, sample sizes, provenance, expert qualifications, ground truth establishment, or any details related to a clinical study or AI/ML algorithm evaluation.

    The document is purely administrative, detailing the device's classification, intended use, and a declaration of substantial equivalence to predicate devices, which is a regulatory pathway for approval, not a performance study.

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