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510(k) Data Aggregation

    K Number
    K191274
    Device Name
    BonAlive Granules
    Manufacturer
    BonAlive Biomaterials Ltd.
    Date Cleared
    2019-08-07

    (86 days)

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

    BonAlive Biomaterials Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.
    Device Description
    BonAlive® granules is composed of osteostimulative calcium-phosphorous-sodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area. In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone. The BonAlive® granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the BonAlive® granules is radiodense thus enabling postoperative radiologic evaluation. Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use. BonAlive® granules is sterilized by irradiation and is available in different granule and unit sizes.
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