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510(k) Data Aggregation

    K Number
    K081758
    Device Name
    HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2008-09-03

    (75 days)

    Product Code
    MQV,FMF
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K012751,K043308,K062495,K003286,K043261,K030208
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may he surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

    The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.

    Device Description

    HEALOS Fx Injectable Bone Graft Replacement is a mineralized collagen matrix processed into lyophilized fibrous material for surgical implantation. The principal components of the HEALOS Fx Injectable Bone Graft Replacement are Type I bovine collagen and hydroxyapatite. HEALOS Fx is approximately 20-30% mineral by weight.

    The HEALOS Fx Graft Mixing and Delivery System is designed to facilitate the mixing of autogenous bone marrow aspirate with the HEALOS Fx material and to deliver this bone graft mixture into the surgical site. Included in the kit are two chambers: a mixing chamber and a delivery chamber.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a medical device called HEALOS® Fx Injectable Bone Graft Replacement and its associated Mixing and Delivery System. This document is a regulatory submission to the FDA, primarily focusing on establishing substantial equivalence to predicate devices for market clearance.

    As such, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

    The "Performance Data" section explicitly states: "No performance standards have been established for this type of device." This indicates that the regulatory pathway for this device did not require a study with quantitative performance metrics against pre-defined acceptance criteria for the purpose of this 510(k) submission. Instead, the focus is on a comparison to existing legally marketed devices.

    Therefore, I cannot provide the requested information from this document.

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