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The MYKRES Spinal 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 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 MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. When used as an anterior, noncervical screw fixation system, the MYKRES Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, or failed fusion (pseudarthrosis).

The subject of this submission is the addition of new system components to facilitate use of the MYKRES Spinal System for anterior noncervical spinal fixation and the addition of such an indication to the statement of intended use. The MYKRES Spinal System, consisting of rods, screws, hooks, connectors and washers, was cleared under K051704 for posterior noncervical spinal fixation. Three new components are available for use in various combinations with certain components previously cleared for posterior spinal fixation

The MYKRES Spinal 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological imparment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudathrosis). The MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The MYKRES Spinal System is an internal fixation device for spinal surgery consisting of rods, screws, hooks and connectors available in various lengths, diameters, and configurations to enable close conformance to patient anatomy. A series of manual instruments (not a subject of this submission) intended to assist in the insertion and placement of the implants is provided in separate trays. The rods, screws, hooks and connectors of the MYKRES Spinal System are made of Ti-6Al-4V titanium alloy conforming to ASTM F 136.