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1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are: The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. 2. Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are: The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: - degenerative spondylolisthesis with objective evidence of neurological impairment, - fracture, - dislocation, - scoliosis, - kyphosis, - spinal tumor, and - failed previous fusion pseudarthrosis)

The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously. The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.