BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

    PMA: P000054 · Supplement: S076 · Decision Feb 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
    Trade Name
    INFUSE Bone Graft
    PMA Number
    P000054
    Supplement Number
    S076
    Device Class
    FDA Class 3
    Product Code
    MPW
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 24, 2026
    Date Received
    January 28, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to upgrade the EO Sterilization Chamber Control System at the contract sterilization site from the Antares Chamber Control System to the Konnexis AccuSOLO Chamber Control System

    Classifications

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

    Product Code Device Name
    MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction