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510(k) Data Aggregation

    K Number
    K050819
    Device Name
    CHARLOTTE SNAP-OFF SCREW
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2005-04-11

    (11 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K043583
    Predicate For
    K111678,K120390,K121277,K130627,K131722,K133713,K140397
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

    • · Fixation of Small Bone Fragments
    • · Weil osteotomy
    • · Mono-cortical fixation
    • · Osteotomies and fractures fixation in the foot and hand
    Device Description

    The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
    Screw

    • Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
    • Available in one diameter and three lengths .
    • Self drilling and self tapping features on distal threads .
    AI/ML Overview

    The provided text describes the CHARLOTTE™ Snap-Off Screw and states that its substantial equivalence was confirmed by testing conforming to ASTM F543-02. However, the document does not explicitly state acceptance criteria or provide a detailed study report with device performance metrics against specific criteria.

    Therefore, I cannot populate the table with acceptance criteria and reported device performance from the provided text. Additionally, the document does not contain information on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

    Based on the provided text, none of the specific details required for your request are available.

    The document primarily focuses on:

    • The intended use and device description of the CHARLOTTE™ Snap-Off Screw.
    • Stating its substantial equivalence to a previously cleared device (K043583).
    • Mentioning conformance to ASTM F543-02 as the basis for confirming substantial equivalence, which is a standard for metallic medical bone screws.
    • The FDA's 510(k) clearance letter.

    To fully answer your request, a detailed study report or the specific performance data against ASTM F543-02 would be needed.

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