BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Resorbable, For Articular Osteochondral Repair

    PMA: P210034 · Decision Mar 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Implant, Resorbable, For Articular Osteochondral Repair
    Trade Name
    Agili-C
    PMA Number
    P210034
    Device Class
    FDA Class 3
    Product Code
    QRU
    Generic Name
    Implant, resorbable, for articular osteochondral repair
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 29, 2022
    Date Received
    September 30, 2021
    Expedited Review
    N
    Docket Number
    22M-0481

    Advisory Committee Statement

    Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QRU Implant, Resorbable, For Articular Osteochondral Repair