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510(k) Data Aggregation

    K Number
    K180853
    Device Name
    EP Granules™ BVF
    Manufacturer
    Elute, Inc.
    Date Cleared
    2018-08-06

    (126 days)

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

    Elute, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EP Granules™ BVF is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EP Granules™ BVF resorbs and is replaced with bone during the healing process.
    Device Description
    EP Granules™ BVF is an osteoconductive device comprising hydroxyapatite (HA) and calcium carbonate (CaCO3) and calcium chloride (CaCl2) particles bound together with a degradable polymer-based binding matrix of poly(caprolactone) (PCL), poly(ethylene glycol) (PEG), and poly(lactide-co-glycolide) (PLGA). The hydroxyapatite and calcium carbonate particles are dispersed throughout the entire structure of the device. Upon implantation, the ceramic hydroxyapatite and calcium carbonate particles resorb over time. The polymer-based binding matrix also resorb over time. It is supplied sterile in a granulated form of various sizes. When EP Granules™ BVF is placed in direct contact with viable non-infected bone, porous regions form in the device and are infiltrated with bone tissue. Bone formation occurs in apposition to the hydroxyapatite and calcium carbonate surface and within the pores of the device. As the device resorbs, bone and soft tissue grow into the space previously occupied by the device.
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