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510(k) Data Aggregation

    K Number
    K142528
    Device Name
    AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm
    Manufacturer
    Date Cleared
    2014-12-22

    (104 days)

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

    Agent Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Agent Medical - ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones. The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes. The Agent Medical - ArthroBridge System is not for spinal use.
    Device Description
    The Agent Medical - ArthroBridge System is an intramedullary small joint arthrodesis/fusion system for fixation of osteotomies, fractures and reconstruction of the phalanges of the lesser digits in the foot and hand. The Agent Medical - ArthroBridge System is a 2-piece cannulated compression screw system composed of 1). A threaded Proximal Module (in a 4.0, 4.5 & 5.0mm size) that is placed within the proximal phalangeal medullary canal, and 2). A Screw with low profile head (in lengths of 25, 30, 35, 40, 45 and 50mm) that is introduced/threaded into the previously inserted Proximal Module. The Proximal Module is cannulated to fit over an insertion instrument and the Screw is cannulated to fit over a .035" K-wire for guided insertion of both components within the phalangeal digit medullary canal. The threaded advancement of the Screw body within the stationary threaded Proximal Module allows internal compression across the debrided digit joint space for stabilization and eventual fusion/ arthrodesis – and for bone fixation and joint deformity correction. The threaded Proximal Module and Screw with low profile head are manufactured from high strength Ti6Al4V ELI Titanium Alloy with an Anodized Type II surface. Disposable, single use, Cannulated Drills, Guide Wires, and Driver/Depth Gauge instruments are available for insertion of the system. Removal (when necessary) of the device is carried out percutaneously. All Implants and Instruments are packaged 'Sterile' for single use. The method of sterilization is Ethylene Oxide.
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