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The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease. The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation systems forming the completed SIFS construct.

The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fration, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine. The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of carcellous and/or corticocancellous bone graft. The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws. The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The Palisade Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis; trauma, (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicular Fixation System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.

Rampart-T implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.

The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis; trauma, (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Threshold ™ Pedicular Fixation System is an addition to Spineology's Fortress pedicle screw family. The Threshold System consists of cannulated titanium screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.

The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: · Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. - · Trauma (i.e., fracture or dislocation) - · Spondylolisthesis • Tumor The VIATM Spinous Process Fixation System is not intended for stand-alone use.

The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion, and it is not intended for stand-alone use. When the VIA™ Spinous Process Fixation System is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1). The VIA Spinous Process Fixation System consists of a three-piece design. The larger male piece (plate) is comprised of a plate with teeth and a spacer in the middle. The two other additional pieces are plates (with teeth) that contain the female ends of the connection with the male spacer. The two female plates engage with the larger plate independently to accommodate variations in the spinal anatomy. The components are locked together with a set screw after assembly. The spinous process contact areas (with the teeth sections) on both the male and female plates do not vary in size. The central spacer on the male plate varies in height (cephalo-caudad), thus providing the different sizes of the device. All components are composed of titanium alloy (Ti-6A1-4V-ELI ASTM F136). Associated accessories include surgical instruments to facilitate implantation.

The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.