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The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.

TranSl AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or 14-S1 spinal segment (s) as an adjunct to spinal fusion. The AxiaLIF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at LS-SI or L4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF:

The TranS1® AxiaLJF® Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for independently distracting the L5 - S1 or L4-S1 vertebral bodies and inserting bone grafi material (DBM, autograft or autologous blood) into the disc space. The device includes an anterior fixation rod that is implanted through the same approach and is used to lock the construct together.

The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.

TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion. The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The TranS1® AxiaLIF® 2L System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.

TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion. The AxiaLIF® 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion. The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint (usually) at a single level and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process. Bone graft must be used for both fixation methods. For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems. The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.

The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion. The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems. The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1@ AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet and pedicle screw systems.

The TranS1® AxiaLIFTM System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral. axial track to the 1.5 - S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.