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510(k) Data Aggregation

    K Number
    K223915
    Device Name
    Tactoset
    Manufacturer
    Anika Therapeutics. Inc.
    Date Cleared
    2023-03-29

    (90 days)

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

    Anika Therapeutics. Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process and may be combined with autogenous bone marrow. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
    Device Description
    Tactoset is an injectable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.
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    K Number
    K212083
    Device Name
    Tactoset Injectable Bone Substitute
    Manufacturer
    Anika Therapeutics. Inc.
    Date Cleared
    2021-08-31

    (60 days)

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

    Anika Therapeutics. Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
    Device Description
    Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), and water for injection. Tactoset® Injectable Bone Substitute is provided sterile for single use in volumes ranging from 1cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.
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