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The Wiltse 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. The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformittes (including scollosis, kyphosis, and lordosis), tumor, pseudoarthrosis, and revision of failed previous fusion surgery. Other indications include degenerative lumbar scollosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.

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The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass. The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiocraphic studies), soondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and multi-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required. For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/iliac/lamina attachment only. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.

Modification to K954770 - Varigrip device components numbered CGT-SL and CGT-SL-15