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510(k) Data Aggregation

    K Number
    K082267
    Device Name
    PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2008-10-29

    (79 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K061362
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew PiGalileo System TKR is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.) Examples of some surgical procedures include but are not limited to:

    • Total knee replacement supporting bone referencing technique .
    • Total knee replacement supporting ligament balancing technique .
    • Minimally invasive total knee replacement .
    Device Description

    The PiGalileo Navigation System is a software-controlled sterotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.
    The PiGalileo TKR V2.1 and PiGalileo TKR CAS V4.0 applications are surgical techniques for computer assisted navigation that leverages PiGalileo Total Knee Replacement (TKR) instruments as well as a number of non-navigated knee instruments for total knee replacement with the intent to optimally position knee prostheses during total joint arthroplasty.

    AI/ML Overview

    The provided text describes a medical device, PiGalileo TKR V2.1 and TKR CAS V4.0, which is a computer-assisted orthopedic surgery system for total knee replacement. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The text is a 510(k) summary and FDA clearance letter, which mainly focuses on device description, classification, indications for use, and substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information from the given input.

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