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510(k) Data Aggregation

    K Number
    K250346
    Device Name
    BonVie+
    Manufacturer
    Elute Inc.
    Date Cleared
    2025-02-26

    (20 days)

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

    Elute Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BonVie+ is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BonVie+ resorbs and is replaced with bone during the healing process.
    Device Description
    BonVie+ is an osteo-conductive bone void filler. It is supplied sterile in a kit comprised of 1] a pack containing polymers and Ca-salt in powdered form, 2] ampoules containing a biocompatible solution (acetone) for mixing and granulation, and 3] a silicone mat containing cavities of various sizes to form granules of various sizes. The powder formulation comprises hydroxyapatite (HA), calcium carbonate (CaCO3), and calcium chloride (CaCl2) particles with degradable polymers poly(caprolactone) (PCL), poly(ethylene qlycol) (PEG), and poly(lactide-co-dlycolide) (PLGA). The biocompatible solution used for mixing is acetone. Once mixed and granulated, the HA and CaCO3 particles are dispersed throughout the entire structure of the device. Upon implantation, the HA and CaCO3 particles resorb over time. The polymer-based binding matrix also resorb with time. When BonVie+ is placed in direct contact with viable bone and the surrounding biologic fluid environment, porous regions form in the filler material and are infiltrated with bone tissue. Bone formation occurs in apposition to the HA and CaCO3 surface and within the pores of the device resorbs, bone grows into the space previously occupied by the filler material.
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