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510(k) Data Aggregation

    K Number
    K231649
    Device Name
    Intraosseous Fusion Device System
    Manufacturer
    Date Cleared
    2023-09-29

    (115 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Auxano Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including: Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus. The Intraosseous Fusion Device System is not intended for spinal use.
    Device Description
    The Intraosseous Fusion Device (IFD) is a threaded titanium implant that is designed to provide stabilization of bones, bone segments or bone fragments to facilitate arthrodesis. The implant has an interrupted external thread to facilitate placement and fixation. The implant is hollow, which allows packing of bone graft material, and fenestrated, which allows bone growth and formation throughout the implant. The implants come in a variety of diameters (6, 9, 12mm) and lengths (10, 15 & 20mm) to address different anatomy locations. The implants are made from Ti6-6Al-4V alloy. The Intraosseous Fusion Device System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization. The system is provided non-sterile and requires steam sterilization at point of use. Single-use metallic implants are time stable. Reusable instruments are inspected in reprocessing for conditions compromising function. All instruments (except for k-wires) are reusable and can be reprocessed.
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