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510(k) Data Aggregation

    K Number
    K041177
    Device Name
    SYNTHACER; SYNTRICER
    Date Cleared
    2005-06-23

    (414 days)

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

    MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Synthacer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.
    Device Description
    Synthacer® Calcium Salt Bone Void Filler is a porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameter averages 600um and the average porosity is 60 - 80%. The implant is provided sterile in block. cylinder, morsel and ball form. Synthacer® is composed of a calcium phosphate ceramic which is at least 95% pure hydroxyapatite Cas(PO4)3OH. Synthacer® promotes three-dimensional regeneration of bone in the defect site into which it is implanted. When Synthacer® is placed in direct contact with viable host bone, new bone growth occurs in apposition to the calcium phosphate surfaces of the implant. As the Synthacer® is resorbed, bone grows into the space previously occupied by the scaffold the implant provides. Synthacer® is radiopaque. Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for yoids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® should not be used to treat large defects that in the surgeon's opinion would not heal spontaneously. Pore diameter averages 600um and the average porosity is 60 -80%. Syntricer® is composed of a calcium phosphate ceramic which is at least 95% pure tricalcium phosphate Ca3(PO4)2. The implant is provided sterile in block, cylinder, morsel and ball form. Syntricer® is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void, the Syntricer® will slowly resorb and be replaced with bone over time during the healing process.
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