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510(k) Data Aggregation

    K Number
    K110787
    Device Name
    TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
    Manufacturer
    Date Cleared
    2011-04-21

    (31 days)

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

    ORTHOGEM LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TriPore TDDHA, TDDBPS, and TDDgP15 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.
    Device Description
    TriPore TDD is an open bore syringe prefilled with TriPore synthetic bone graft granules in three different compositions: (1) 100% pure hydroxylapatite; (2) biphasic mixture of 90% hydroxlyapatite and 10% tri-calcium phosphate; (3) biphasic mixture of 15% hydroxlyapatite and 85% tri-calcium phosphate TriPore TDD comes in two sizes - containing 5cc and 10cc of TriPore granules.
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    K Number
    K070132
    Device Name
    TRIPORE, MODELS HA, BP90, BP15
    Manufacturer
    Date Cleared
    2007-07-13

    (178 days)

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

    ORTHOGEM LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.
    Device Description
    TriPore HA is pure hydroxylapatite bone void filler, with a highly porous structure comprising three types of porosity which are interconnected: macropores (100 µm to 1-2mm), midipores (10-100 µm) and microspaces (1-10 µm). TriPore BP90 and TriPore BP15 are a biphasic tricalcium phosphate:hydroxylapatite. The (X) designates the nominal hydroxyapatite composition of the mixture. TriPore BP bone void filler has the same structure as TriPore HA. TriPore (HA or BP) is available in Blocks (D-shaped, cuboid and other shapes) and Granules (four different sizes)
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