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510(k) Data Aggregation

    K Number
    K233259
    Device Name
    Xerosyn
    Manufacturer
    Date Cleared
    2024-06-21

    (266 days)

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

    XeroThera Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XeroSyn bone void filler is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). XeroSyn is used with autograft as a bone graft extender in the extremities and pelvis. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. XeroSyn resorbs and is replaced with bone during the healing process.
    Device Description
    XeroSyn bone void filler is a synthetic bone graft substitute designed for use as an autograft extender in the extremities and the pelvis. XeroSyn bone void filler is a sol-gel synthesized bioactive, osteoconductive bone void filler. The chemical composition of XeroSyn is very similar to the predicate, Altapore, containing elements that exist naturally in bone (Ca, P, O, H, Si), albeit at different ratios. The sol-gel synthesis process produces porous microparticles which are silane treated to enhance the particle growth to form the desired granule size. The interconnected highly porous structure of XeroSyn readily absorbs body fluids and facilitates quick and easy mixing with autogenous bone. XeroSyn bone void filler is supplied in a sterile glass vial within a sterile pouch and contains 1 gram of XeroSyn micro-granules sized 20-30 um, 80% total porosity, and appears as a fine white powder. XeroSyn does not set in situ following implantation. XeroSyn is bioactive as supported by the Kokubo test. This in vitro test shows the formation of a surface apatite layer when the synthetic graft material is immersed in a standard simulated body fluid with the ion concentration of human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow.
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