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510(k) Data Aggregation

    K Number
    K141739
    Device Name
    RESIDUAL LIMB LENGTHENING SYSTEM
    Manufacturer
    ELLIPSE TECHNOLOGIES INC.
    Date Cleared
    2014-10-07

    (102 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELLIPSE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.
    Device Description
    The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Ellipse RLL System is a non-weight bearing device.
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    K Number
    K140613
    Device Name
    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    Manufacturer
    ELLIPSE TECHNOLOGIES INC.
    Date Cleared
    2014-09-18

    (192 days)

    Product Code
    PGN
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELLIPSE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
    Device Description
    The MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC Rod to be lengthened or shorten. The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to test the device prior to implantation. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC Rod. The ERC is placed over this location on the child's back.
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    K Number
    K131677
    Device Name
    PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    Manufacturer
    ELLIPSE TECHNOLOGIES INC.
    Date Cleared
    2013-10-11

    (123 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELLIPSE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
    Device Description
    The Ellipse PRECICE System is composed of the modified PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.
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