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510(k) Data Aggregation

    K Number
    K181947
    Device Name
    Persona Revision Knee System
    Manufacturer
    Zimmer Inc.
    Date Cleared
    2018-10-25

    (97 days)

    Product Code
    JWH,MBH,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K133737,K130143,K123459,K122765,K121771,K113369,K173057,K152494,K960279,K946150,K933785,K103517,K040630,K031962,K024161,K171054,K121149,K093293,K042757,K023528,K013031,K982903,K973412,K972501
    Predicate For
    K191625,K210829,K243724
    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.

    • 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.

    Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

    Device Description

    The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
    • Femoral components
    • Articular surfaces
    • Tibial components
    • Stem extensions
    • Femoral and tibial augments
    • Femoral and tibial cones
    The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.

    AI/ML Overview

    This FDA 510(k) summary for the "Persona Revision Knee System" does not describe a study involving an AI/ML device or its performance criteria. It pertains to a physical medical device (a knee prosthesis) and the tests conducted are primarily mechanical and material property assessments, not related to AI/ML performance metrics like sensitivity, specificity, or reader studies.

    Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving an AI/ML device meets them from the provided text. The document focuses on showing substantial equivalence of a knee implant to existing devices through non-clinical (mechanical, material, design) testing and intended use comparisons.

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