BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Resorbable, For Articular Osteochondral Repair

    PMA: P210034 · Supplement: S001 · Decision Jun 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Resorbable, For Articular Osteochondral Repair
    Trade Name
    Agili-C
    PMA Number
    P210034
    Supplement Number
    S001
    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
    June 4, 2026
    Date Received
    December 11, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updated package labeling that incorporates the clinical results from the required postapproval study.

    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