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510(k) Data Aggregation

    K Number
    K112169
    Device Name
    APTUS WRIST ARTHRODESIS PLATES
    Manufacturer
    MEDARTIS AG
    Date Cleared
    2012-01-06

    (162 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K990094,K023879,K042355,K011458,K000558,K051567
    Predicate For
    K192297
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

    Device Description

    The APTUS® Wrist Arthrodesis Plates system is intended to be used for internal fixation of wrist fusions and consists of three titanium locking plates. The plates are secured using previously cleared titanium screws. APTUS Wrist Arthrodesis Plates are provided in various sizes.

    AI/ML Overview

    This document, a 510(k) Summary for the Medartis AG APTUS® Wrist Arthrodesis Plates (K112169), describes a medical device, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects like training sets, ground truth methodology for AI, and MRMC studies are not applicable and not present in the provided text.

    The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, a requirement for 510(k) submissions.

    Therefore, I cannot populate the requested table and details as they relate to AI/ML device performance and testing, which are not covered in this type of submission.

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