Intervertebral Body Fusion Device - India CDSCO Medical Device Registration

Product Information

The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. Certain sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage may also be used with Infuse Bone Graft for patients diagnosed with DDD, as defined above, who are skeletally mature and have had six months of non-operative treatment. The device may be implanted at a single level using an Oblique Lateral Interbody Fusion(CD HORIZON SOLERA Spinal System) approach from L2-L5 and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the Infuse Bone Graft/ Medtronic Interbody Fusion Device for information on the specific sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage approved for use with Infuse Bone Graft, as well as specific information regarding contraindications, warnings and precautions associated with Infuse Bone Graft. Infuse Bone Graft is not indicated for use in a direct lateral Interbody fusion(CD HORIZON SOLERA Spinal System) surgical approach. Additionally, PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. Infuse Bone Graft is not indicated for use in patients with this condition. The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (CD HORIZON SOLERA Spinal System) of the vascular structures, and oblique or lateral above the bifurcation (CD HORIZON SOLERA Spinal System) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (CD HORIZON SOLERA Spinal System) of the vascular structures, and oblique or lateral above the bifurcation (CD HORIZON SOLERA Spinal System) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (CD HORIZON SOLERA Spinal System) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (CD HORIZON SOLERA Spinal System); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1(CD HORIZON SOLERA Spinal System). These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels