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510(k) Data Aggregation

    K Number
    K181067
    Device Name
    AlignX Ankle Fusion System
    Manufacturer
    Extremity Medical, LLC
    Date Cleared
    2018-05-23

    (30 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K160191,K141735,K132591,K133691
    Why did this record match?
    Device Name :

    AlignX Ankle Fusion System

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

    The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

    Device Description

    The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical, anterior and lateral tibia plates and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plates are available in various geometries. The anterior plate is available three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalar (TT) or (tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy. The lateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one for tibiotalarcalcaneal (TTC) fusions.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the "AlignX Ankle Fusion System." This summary does not include acceptance criteria or the results of a study proving a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and the assertion that no clinical testing was performed.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size, ground truth, or expert qualifications based on the given text.

    The document states:

    • "No clinical testing was performed."
    • "An engineering analysis demonstrated that the new plates and screw sizes do not introduce a new worse case in terms of strength."

    This indicates that equivalence was established through non-clinical testing (engineering analysis) and comparison to predicate devices, rather than through a study with acceptance criteria often seen with performance claims for AI/ML devices or diagnostic tools.

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