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510(k) Data Aggregation

    K Number
    K051951
    Device Name
    CERAMENT BONE VOID FILLER
    Manufacturer
    BONE SUPPORT AB
    Date Cleared
    2005-09-28

    (72 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BONE SUPPORT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    Cerament™ is an injectable bone mineral substitute material intended for stabilization of fractured osteoporotic bone void. The material consists of a powder and a liquid component. The major constituents of the powder component are calcium sulphate hemihydrate and hydroxyl apatite and the liquid component is the radio-contrast agent Iohexol. Mixing of the powder and liquid components results in a viscous mixture suitable for percutaneous injection into the fractured bone void. During resorption of the calcium sulfate dihydrate, the hydroxy apatite remains intact providing osteoconductive support for the in-growth of new bone, which gradually replaces the resorbed calcium sulfate dihydrate. The bone mineral substitute material is injected into the bone void in a percutaneous procedure with the use of an accompanying injection device. Prior to injection, the powder and liquid components of the substitute material are mixed in a mixing container. The substitute material is injected into the bone void during careful radiographic inspection until the bone void is filled as judged from the radiographic image.
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