BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Zimmer® Persona® Personalized Knee System

    K Number: K243293 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    5
    Review Days
    63

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    Basic Information

    Device Name
    Zimmer® Persona® Personalized Knee System
    K Number
    K243293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Biomet
    Date Received
    October 18, 2024
    Decision Date
    December 20, 2024
    Product Code
    MBH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by Zimmer Biomet

    K Number Device Name
    K251834 Persona Partial Knee
    K243571 Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
    K251620 A.L.P.S. Proximal Humerus Plating System
    K250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)