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

    Zimmer® Persona® Personalized Knee System

    K Number: K251840 · Decision May 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    376
    Review Days
    346

    Basic Information

    Device Name
    Zimmer® Persona® Personalized Knee System
    K Number
    K251840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    June 16, 2025
    Decision Date
    May 28, 2026
    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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