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510(k) Data Aggregation

    K Number
    K102380
    Device Name
    EVOLUTION MP TOTAL KNEE SYSTEM
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2011-01-07

    (137 days)

    Product Code
    JWH,HRY
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K093552,K063731,K033890,K973524,K972626,K960617,K894334
    Predicate For
    K113325,K140735,K182251,K243574
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

    1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
    2. inflammatory degenerative joint disease including rheumatoid arthritis;
    3. correction of functional deformity;
    4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
      The EVOLUTION™ Total Knee System is for cemented use only.
    Device Description

    The subject of this Special 510(k)-Premarket Notification is to request a performance specification modification to increase the functional range of motion for the Wright Medical Technology, Inc. EVOLUTION™ MP Total Knee System. The EVOLUTION™ MP Total Knee System consists of existing total knee implant devices. No new total knee components are being introduced as a result of this Special 510(k) premarket notification.
    The EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing. A review of these results indicates that the EVOLUTION™ MP Total Knee System is equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a knee system, and it does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI/ML device.

    The document states that the "EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing." However, this refers to the physical knee system, not an AI/ML device.

    Therefore, I cannot provide the requested information for an AI/ML device based on the given text.

    If you have a document related to an AI/ML device with acceptance criteria and performance study details, please provide that.

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