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510(k) Data Aggregation

    K Number
    K021502
    Device Name
    OSCAR, MODEL OE3000
    Manufacturer
    ORTHOSONICS, LTD.
    Date Cleared
    2002-06-06

    (28 days)

    Product Code
    LZV
    Regulation Number
    888.4580
    Why did this record match?
    Product Code :

    LZV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthosonics OSCAR OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
    Device Description
    The currently marketed Orthosonics OSCAR Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, and a set of cement removal probes. The primary change to the system is the addition of a laparoscopic video system, which can aid the clinician in examining the inside of the bone that is having its glue removed. This part of the system would only be used when the ultrasound-powered probes are not being used. The laparoscope and optical coupler are currently marketed medical devices. In order to make room for the video module in the main system unit of the OE3000, the ultrasonic power modules were reduced in physical size. In addition, the currently marketed device now has an optional accessory that was added to the system via a letter-to-file, without filing a new 510(k). The change involves adding a "slap hammer" that can be attached to an "extraction" probe, to aid in removal of a PMMA cement plug that is NOT firmly bonded to the endosteal interface. The Extraction Probe to be used with the slap hammer is a modified version of the piercer probe that was cleared with the original 510(k).
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    K Number
    K961101
    Device Name
    STRYKER CEMENT REMOVAL SYSTEM
    Manufacturer
    STRYKER CORP.
    Date Cleared
    1996-07-15

    (118 days)

    Product Code
    LZV
    Regulation Number
    888.4580
    Why did this record match?
    Product Code :

    LZV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.
    Device Description
    The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadnium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidfy around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.
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