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510(k) Data Aggregation

    K Number
    K230908
    Device Name
    Hand Trauma Threaded Nail System
    Manufacturer
    Skeletal Dynamics, Inc.
    Date Cleared
    2023-04-28

    (28 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K220723
    Why did this record match?
    Device Name :

    Hand Trauma Threaded Nail System

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

    The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.

    Device Description

    The Skeletal Dynamic's Hand Trauma Threaded Nail System consists of cannulated and noncannulated threaded nails, with distal and proximal threads with a pitch differential between the threads which creates compression during threaded nail insertion. The threaded nails are selftapping, available in multiple diameters and various lengths and made of titanium alloy.

    • 2.0mm non-cannulated Hand Trauma Threaded nail:12mm-28mm in 2mm increments
    • 2.0mm non-cannulated Hand Trauma Threaded Nails: 28mm 48mm in 4mm increments.
    • · 3.0mm cannulated Hand Trauma Threaded Nails: 20mm 70mm in 5mm increments.
    • · 3.5mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
    • · 4.0mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.

    The system is provided non-sterile and is sterilized in the user facility.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (Hand Trauma Threaded Nail System), which primarily addresses substantial equivalence to a predicate device based on similar indications for use, design, materials, and performance.

    The "Performance Testing" section mentions that "Axial Pullout Strength" testing was performed to verify the addition of smaller sizes, and that this testing followed FDA guidance. It concludes that the new sizes are "as safe and effective as the predicate device." However, specific acceptance criteria for this test and detailed results are not provided in the given text.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study to prove they are met, including sample sizes, ground truth establishment, or expert involvement, as this information is not present in the input.

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