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

    Persona Partial Knee

    K Number: K251834 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    5
    Review Days
    60

    Basic Information

    Device Name
    Persona Partial Knee
    K Number
    K251834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Biomet
    Date Received
    June 16, 2025
    Decision Date
    August 15, 2025
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HSX), ordered by most recent decision date.

    Tahoe Unicondylar Knee System with TiNbN Overcoat

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cambridge Partial Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOTO Partial Knee System Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex iBalance Partial Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIFY™ Unicondylar Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Zimmer Biomet

    K Number Device Name
    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)
    K243293 Zimmer® Persona® Personalized Knee System