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510(k) Data Aggregation

    K Number
    K231528
    Device Name
    Bonalive Orthopedics granules
    Manufacturer
    Bonalive Biomaterials, Ltd.
    Date Cleared
    2023-07-11

    (46 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® Orthopedics granules is an implant intended to fill bony voids or gaps of the skeletal system. (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process.
    Device Description
    Bonalive® Orthopedics granules is composed of osteostimulative calcium-phosphoroussodium-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 P₂O₃. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its abilitate 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® Orthopedics granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the Bonalive® Orthopedics 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® Orthopedics granules is sterilized by irradiation and is available in different granule and unit sizes.
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