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The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle: Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time The the worst case validated sterilization load is: -One (1) Supplemental Instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 lbs.); in a non-stacked configuration. The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions: Supplemental Instrument Tray (Model SIT1-000) | Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumens | |------------------|-----------------------------|-------------------------------------|------------------| | TCD1-000 | Teardrop Cannulated Driver | 0.210" x 4.58" | 1 | | CED1-011 | 11mm Cannulated Entry Drill | 0.146" x 10.75" | 1 | | GWC1-000 | Guide Wire Chuck | 0.250" x 5.0" | 1 | | LQC1-000 | Large AO Quick Connect | 0.175" x 2.91" | 1 | | DGA1-000 | Direct AO Depth Gauge | 0.394" x 10.43" | 1 | The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions: Supplemental Reamer Tray (Model SRT1-000): | Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumen | |------------------|-------------------------|-------------------------------------|-----------------| | RMR1-110 | Flexible Reamer, 10.0mm | 0.125" x 18.4" | 1 | | RMR1-135 | Flexible Reamer, 13.5mm | 0.125" x 18.4" | 1 | | RMR1-140 | Flexible Reamer, 14.0mm | 0.125" x 18.4" | 1 | | RMR1-145 | Flexible Reamer, 14.5mm | 0.125" x 18.4" | 1 | | RMR1-150 | Flexible Reamer, 15.0mm | 0.125" x 18.4" | 1 | Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray. Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.

The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a Supplemental Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth), and is designed to hold 12 instruments. The Supplemental Reamer Tray has the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth), and is designed to hold 18 flexible reamer instruments. An insert tray with the following dimensions is used with the Supplemental Reamer Tray: 497 mm (length) x 240 mm (width) x 52 mm (depth). The Ellipse Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade, Class VI Silicone.

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). 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 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.

The Ellipse MAGEC 2 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.

The MAGEC 2 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 implanted MAGEC 2 rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to noninvasively distract the implanted spinal rod. The titanium MAGEC 2 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, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC 2 rod. 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 2 System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC 2 rod. The ERC is placed over this location on the child's back.

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The 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.

The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and 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. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.