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

    AETOS Shoulder System Stemless Humeral Prosthesis

    K Number: K240716 · Decision Nov 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    16
    Applicant Total
    83
    Review Days
    250

    Basic Information

    Device Name
    AETOS Shoulder System Stemless Humeral Prosthesis
    K Number
    K240716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc.
    Date Received
    March 15, 2024
    Decision Date
    November 20, 2024
    Product Code
    PKC
    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
    PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

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