BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P100006 · Decision Sep 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    AUGMENT BONE GRAFT
    PMA Number
    P100006
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 1, 2015
    Date Received
    February 4, 2010
    Expedited Review
    N
    Docket Number
    15M-3257

    Advisory Committee Statement

    APPROVAL FOR AUGMENT® BONE GRAFT. THIS DEVICE IS INDICATED FOR USE AS AN ALTERNATIVE TO AUTOGRAFT IN ARTHRODESIS (I.E., SURGICAL FUSION PROCEDURES) OF THE ANKLE (TIBIOTALAR JOINT) AND/OR HINDFOOT (INCLUDING SUBTALAR, TALONAVICULAR, AND CALCANEOCUBOID JOINTS, ALONE OR IN COMBINATION), DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AVASCULAR NECROSIS, JOINT INSTABILITY, JOINT DEFORMITY, CONGENITAL DEFECT, OR JOINT ARTHROPATHY IN PATIENTS WITH PREOPERATIVE OR INTRAOPERATIVE EVIDENCE INDICATING THE NEED FOR SUPPLEMENTAL GRAFT MATERIAL.

    Classifications

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

    Product Code Device Name
    NOX Filler, Bone Void, Synthetic Peptide