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The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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. In addition, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is 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). When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The Jemo Spine, LLC, DELTA™, Spinal Fusion System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, cap/set screws, and a transverse (cross) linking mechanism. The Jemo Spine, LLC, DELTA™, Spinal Fusion System implant components are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Jemo Spine, LLC, DELTA™, Spinal Fusion System can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Jemo Spine, LLC, DELTA™, Spinal Fusion System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled bi-polar cup and internal saddle in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon interface of the cap/set screw assembly with the rod. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Jemo Spine, LLC, DELTA™, Spinal Fusion System implants.