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510(k) Data Aggregation

    K Number
    K122765
    Device Name
    PERSONA NATURAL TIBIA BASEPLATES
    Manufacturer
    ZIMMER INC.
    Date Cleared
    2012-11-09

    (60 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K113369
    Predicate For
    K130143,K152252,K172524,K181947
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is indicated for patients with severe knee pain and disability due to:

    • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -
    • Collagen disorders, and/or avascular necrosis of the femoral condyle. ﻴﻴﻴ
    • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
    • Moderate valgus, varus, or flexion deformities. -
    • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

    This device is intended for cemented use only.

    Device Description

    The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System.

    AI/ML Overview

    This is not an AI medical device. The provided text describes a 510(k) premarket notification for a Persona™ Natural Tibia™ Baseplate and Instrumentation, which is a knee joint prosthesis. The document explicitly states:

    "Non-Clinical Performance and Conclusions: The following tests have been completed in support of the changes to the Persona Natural Tibia Baseplate: Fixation Testing, Cantilever Fatigue Testing, Bending Fatigue Testing of the keel and stem extension junction, and Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

    This means the device's performance was evaluated through non-clinical mechanical and analytical tests, not through studies involving AI or its performance in interpreting medical images or data. Therefore, the requested information regarding acceptance criteria and performance related to AI, ground truth, expert adjudication, or MRMC studies for an AI device is not applicable to this submission.

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