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510(k) Data Aggregation

    K Number
    K202639
    Device Name
    si-Mochi
    Manufacturer
    Date Cleared
    2021-04-21

    (222 days)

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

    Biostone Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, 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. si-Mochi resorbs and is replaced with bone during the healing process.
    Device Description
    si-Mochi contains a multi porous bi-phase Calaium Phosphate ceramic granules, 1~2mm, suspended in an aqueous polymer carrier gel. The chemical composition of the multi-porous ceramic granules is trace silicate induced bi-phase calcium phosphate ceramic which has 80% hydroxylapatite Ca5(PO4)3(OH) and 20% beta -tricalcium phosphate Ca3(PO4)2 , similar levels to those identified in naturally-growing bone. Its porous structure comprising three types of porosities which are interconnected: macropores (100µm~1mm), midipores (10~100 µm) and microspaces (1~10 µm). Calcium phosphate bone graft substitutes have been the topic of extensive clinical studies for several decades. Biocompatibility is addressed in the non-clinical testing section below. The interconnected macro-, midi- and micro- porous structure encourages the rapid formation of host bone and the growth of capillary blood vessels throughout the network of interconnecting pores. After implantation, si-Mochi undergoes physiologically- mediated resorption and is replaced by natural bone. The resorption of the Ca/P porous ceramic granules were controlled by the host nature bone remodelling process due to the proliferated osteocytes formation within the microporous structure of the ceramic granules. The resorption is not controlled by its chemical composition. si-Mochi is supplied in three different types of sterile applicator. si-Mochi does not set in-situ following implantation. si-Mochi does not contain antibiotics.
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