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510(k) Data Aggregation

    K Number
    K081374
    Device Name
    CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2008-09-09

    (116 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE

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

    The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

    The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

    Device Description

    The CHARLOTTE™ LisFranc Bone Screw is offered in 2 diameters and a range of lengths to accommodate variability among patients. All screws are made from stainless steel.

    The CHARLOTTE™ LisFranc Plate consists of plates, non-locking screws, and locking screws. All components are manufactured from stainless steel.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (bone screw and plate) and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-based diagnostic devices.

    The document focuses on establishing substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria through a clinical or analytical study.

    Therefore, I cannot provide the requested information. The document explicitly states:

    • "The safety and effectiveness of the CHARLOTTE™ LisFranc Bone Screw and CHARLOTTE™ LisFranc Plate are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification." (Page 1, Section C)

    This implies that the submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data from human or AI-based evaluations.

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