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510(k) Data Aggregation

    K Number
    K040381
    Device Name
    HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2004-05-12

    (85 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use for HATriC™ is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriC™ may be used as a bone graft substitute for autograft or allograff when these grafts are undesirable or unavailable.

    When used for posterolateral fusions, the HATriC™ must be used with autograft bone material and the ratio of autograft bone material to HATriC™ must be in the range of 1.25cm³ of autograft bone to 1cm3 of HATriC™.

    HATriC™ is a bone void filler or bone graft substitute that resorbs and is replaced with bone during the healing process. HATriC™ is not intended to be a load-bearing device. Therefore rigid fixation techniques may often be recommended.

    In addition, when used with Arthrex Opening Ostectorny Systems' or substantially equivalent systems' plates and screws, HATriC™ is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies. HATriC™ is to be used in association with adequate post-operative immobilization.

    Device Description

    HATriC™ is a bone void filler or bone graft substitute. HATriC™ is designed as a block of two-phase ceramic calcium phosphate consisting of 60% hydroxyapatite and 40% B-tricalcium phosphate in a wedge configuration. HATriC™presents as a multidirectional interconnected porosity structure, similar to that of hyman cancellous bone. The HATriC™ implant resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the HATriC™ bone void filler, detailing its description, intended use, and substantial equivalence to predicate devices, and an FDA letter granting marketing clearance.

    Therefore, I cannot populate the requested table and study details.

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