Orthosis, spinal pedicle fixation, for degenerative disc disease - India CDSCO Medical Device Registration

Product Information

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated as an adjunct to fusion for one or more of the following: (CD HORIZON SOLERA Spinal System) degenerative disc disease (CD HORIZON SOLERA Spinal System), (CD HORIZON SOLERA Spinal System) degenerative spondylolisthesis with objective evidence of neurologic impairment, (CD HORIZON SOLERA Spinal System) fracture, (CD HORIZON SOLERA Spinal System) dislocation, (CD HORIZON SOLERA Spinal System) scoliosis, (CD HORIZON SOLERA Spinal System) kyphosis, (CD HORIZON SOLERA Spinal System) spinal tumor, and/or (CD HORIZON SOLERA Spinal System) failed previous fusion (CD HORIZON SOLERA Spinal System). In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using bone graft: (CD HORIZON SOLERA Spinal System) having severe spondylolisthesis (CD HORIZON SOLERA Spinal System) of the fifth lumbar-first sacral (CD HORIZON SOLERA Spinal System) vertebral joint: (CD HORIZON SOLERA Spinal System) who are receiving fusions using autogenous bone graft only: (CD HORIZON SOLERA Spinal System) who are having the device fixed or attached to the lumbar and sacral spine (CD HORIZON SOLERA Spinal System); and (CD HORIZON SOLERA Spinal System) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (CD HORIZON SOLERA Spinal System) degenerative disc disease (CD HORIZON SOLERA Spinal System), (CD HORIZON SOLERA Spinal System) spondylolisthesis, (CD HORIZON SOLERA Spinal System) fracture, (CD HORIZON SOLERA Spinal System) spinal deformities (CD HORIZON SOLERA Spinal System), (CD HORIZON SOLERA Spinal System) spinal stenosis, (CD HORIZON SOLERA Spinal System) pseudarthrosis, (CD HORIZON SOLERA Spinal System) tumor resection, and/or (CD HORIZON SOLERA Spinal System) unsuccessful previous attempts at spinal fusion. When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (CD HORIZON SOLERA Spinal System); spinal stenosis; curvatures (CD HORIZON SOLERA Spinal System); tumor; pseudarthrosis; and/or failed previous fusion.For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis