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510(k) Data Aggregation

    K Number
    K220723
    Device Name
    Hand Trauma Screw System
    Manufacturer
    Skeletal Dynamics, Inc.
    Date Cleared
    2022-05-12

    (59 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K201662,K133842
    Predicate For
    K230908
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation.

    • 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments. ●
    • 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
    • 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
    • 4.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
      The system is provided non-sterile and is sterilized in the user facility.
    AI/ML Overview

    This FDA 510(k) clearance document for the "Hand Trauma Screw System" does not describe an AI/ML device. It pertains to a physical medical device (bone screws) and therefore the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document.

    The document discusses substantial equivalence based on:

    • Engineering analysis
    • Mechanical testing (ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws)

    It concludes that the device is substantially equivalent to predicate devices based on similarities in intended use, indications for use, materials, design, performance, sterility, and packaging. There is no mention of an algorithm, AI, or specific performance metrics related to diagnostic or predictive capabilities.

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