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IRENE Thoracolumbar Fixation System provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: ( ) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The proposed device consists of pedicle screws, reduction screws, titanium rods and transverse connectors in various sizes, providing immobilization and stabilization of spinal segments through bridge connection between these components. The proposed device is made of titanium alloy per ASTM F136, and is intended for single-use. The proposed device includes three sub-systems, which are named as PLATINUM 5.5M Thoracolumbar Fixation System (NS2), TITANTM 5.5mm Thoracolumbar Fixation System and PLATINUM 6.35 Thoracolumbar Fixation System (NS3), all the devices use the same material and similar design principle, there are slight differences in design and parts size among these three sub-systems which does not raise different questions of safety and effectiveness. There is no surface modification or coating. The proposed devices are supplied non-sterile. It is required to be sterilized via moist heat to reach a SAL of 106 prior to surgery. The sterilization method is presented in the instructions for use, which has been validated per ISO 17665-1.