BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P860005 · Supplement: S009 · Decision Apr 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Filler, Bone Void, Non-Osteoinduction
    Trade Name
    PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
    PMA Number
    P860005
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MBS
    Generic Name
    Filler, bone void, non-osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 28, 1998
    Date Received
    October 27, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for several labeling changes as identified and agreed upon in an April 17, 1998 facsimile of the labeling. The device name will also be modified and will be marketed under the trade name "Pro Osteon(R) Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks and Granules." The device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects. For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month of fracture. The device is to be used in conjunction with rigid internal fixation as dictated by the clinical use requirements in skeletally mature individuals.

    Classifications

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

    Product Code Device Name
    MBS Filler, Bone Void, Non-Osteoinduction