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

    Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

    K Number: K253637 · Decision Feb 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    30
    Review Days
    91

    Basic Information

    Device Name
    Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
    K Number
    K253637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp., Dba Stryker Orthopaedics
    Date Received
    November 19, 2025
    Decision Date
    February 18, 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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