Search Results

The Wenzel Spine VariLift-C Interbody Fusion System is indicated for use in skeletally mature patients with cervical disc degeneration (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2/C3 to C7/T1. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Wenzel Spine VariLift-C Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach using autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used at one disc level, the Wenzel Spine VariLift-C interbody Fusion System may be used with or without supplemental fixation. When used at multiple contiguous levels, the Wenzel Spine VariLift-C Interbody Fusion System is intended to be used with supplemental fixation. Patients should have at least six (0) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The VariLift® Cervical Interbody Fusion device (VariLift-C) is a self-tapping, expandable device with an interior sliding wedge. VariLift-C is cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The grooved and fluted fusion device has fenestrations (graft windows) positioned between each of its four quadrants to allow bony ingrowth and contact with the endplates. The device is manufactured from medical grade titanium alloy (Ti6Al4V) per ASTM F136.

The primaLOK™ SP Interspinous Fusion 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), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.

The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).

The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L/LX and VariLift®-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

VariLift-LX Interbody Fusion Device: The VariLift-LX is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift-LX devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile. The VariLift-LX Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-C Interbody Fusion Device: The Wenzel Spine VariLift Cervical Interbody Fusion System is a self-tapping, expandable device with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6A1-4V ELI alloy that conforms to ASTM F136. The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The device is supplied sterile.

The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift®-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-L and VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion.

The VariLift®-L Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach. The VariLift®-L is a selftapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift®-L devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile. A design change was made on all sizes of the VariLift®-L devices to increase the surface in contact at the superior and inferior vertebrae. Additionally dimensional modification were made to the instrumentation to ensure all instruments work with all sizes of the modified devices.

The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of decenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bl-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

The Wenzel Spine VariLift Interbody Fusion System is offered in two (2) configurations of various sizes that are designed based on surgical approach, and consist of: - 1) VariLift-L®, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach. - 2) VariLift-A®, which may be implanted bi-laterally via an anterior (ALIF) approach. A design change was made on all sizes of the VariLift-L® devices to eliminate the risk of orientation error when loading the implant on the insertion instruments. Additionally, dimensional and threadform modifications were made to the instrumentation to ensure all instruments work with the modified devices. The VariLift-L® and VariLift-A® are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. They are grooved and fluted devices with large fenestrations (graft windows) positioned between each of the four quadrants that provide bony contact with the endplates. The devices are made of titanium alloy (per ASTM F136).

The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6Al-4V ELI alloy that conforms to ASTM F136. The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The device is supplied in an appropriately labeled sterile packaging. The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136. The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The device is supplied in an appropriately labeled sterile packaging. The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

The Wenzel SpineVariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

The proposed Wenzel Spine VariLift Interbody Fusion System will be offered in two (2) configurations of various sizes that are designed based on indicated spinal implant level and surgical approach, and consist of: - 1) VariLift-L, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach. - 2) VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach. The VariLift-L and VariLift-A are grooved and fluted devices with large fenestrations (araft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The VariLift-L and VariLift-A are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.