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510(k) Data Aggregation

    K Number
    K152589
    Device Name
    Bio2 CLM BG Bioactive Scaffold
    Date Cleared
    2016-01-12

    (124 days)

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

    Bio2 Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bio2 CLM•BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The material can be drilled and tapped, and screws can be placed through it. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
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    K Number
    K151876
    Device Name
    Bio2 Fusion Implant System
    Date Cleared
    2015-12-30

    (174 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bio2 Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization. When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.
    Device Description
    The Bio2 Technologies Fusion Implant is a cylindrical shaped implant designed for fracture fixation repair, osteotomy and to fit into the proximal and distal sides of the proximal interphalangeal joints of the foot or hand. The implants are made of bioactive glass material that has been demonstrated to be biocompatible and osteoconductive. The implants are available in multiple diameters, lengths and in a straight and angled configuration. The implants are provided sterile and are intended for single use.
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    K Number
    K142463
    Device Name
    Bio2 CLM BG Bioactive Scaffold
    Date Cleared
    2014-12-18

    (107 days)

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

    Bio2 Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bio2 CLM-BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CL.M+BG Bioacive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremitics and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
    Ask a Question

    Ask a specific question about this device

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