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510(k) Data Aggregation

    K Number
    K163039
    Device Name
    ORTHOLOC® 3Di Small Bones Plating
    Manufacturer
    Wright Medical Technology, Inc.
    Date Cleared
    2017-03-13

    (133 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K152974,K090692
    Why did this record match?
    Device Name :

    ORTHOLOC**®** 3Di Small Bones Plating

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

    The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles. The system can be used in both adult and pediatric patients. Examples include:

    • Metatarsal, metacarpal, or phalangeal fractures and osteotomies
    • Lesser metatarsal shortening osteotomies (e.g. Weil)
    • Fifth metatarsal fractures (e.g. Jones Fracture)
    Device Description

    The ORTHOLOC® 3Di comprises of variety of plates and screws for fixation of bone fragments. The subject device is composed of titanium alloy per ASTM F136. This system consists of plates in left, right, and universal configurations. The plates can feature polyaxial locking holes and compression holes. The plates are provided non-sterile.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for the ORTHOLOC® 3Di Small Bones Plating System, outlining its substantial equivalence to previously marketed devices. It primarily discusses the device's intended use, technological characteristics, and non-clinical and clinical evidence provided for FDA clearance.

    The document states:

    • (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending."
    • (b)(2). Substantial Equivalence Clinical Evidence: "N/A"

    This indicates that the clearance was based on non-clinical performance testing against a predicate device, rather than a clinical study with detailed acceptance criteria, ground truth establishment, or human reader performance evaluations as typically seen for AI/software-as-a-medical-device (SaMD) products.

    Therefore, I cannot provide the requested table or details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on this document.

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