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The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft. Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s). The PATHWAY ELIF device can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

The PATHWAY ELIF implant features three prescribed lordotic angle / height positions and is available in two lengths for posterior lumbar fusion. It allows lordotic adaptability and height restoration to meet patient anatomy. It is comprised of upper and lower expandable surfaces preassembled with a posterior height maintenance component. The device can be expanded to fixed configurations of 0°, 8°, and 16° positions. Each position after 0° provides approximately 2mm of additional mid-body height increase. The superior and inferior surfaces of all components are coated with plasma sprayed titanium to provide a roughened finish.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment. The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies. The device is available in two footprints, multiple heights, lordotic angles and screw lengths.

The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: · - . Trauma, including spinal fractures and/or dislocation - . Spondylolisthesis - Spondylolysis ● - . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity - . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). - . Degeneration of the facets with instability

The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum.

The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).

The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).

The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft. Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device. The PATHWAY device can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.

The proposed modification to the PATHWAY Intervertebral Body Fusion Devices (PLIF and TLIF) is to The proposed mountedion with the currently cleared titanium (Ti-6Al-4V) markers.

The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: For pedicular use: When used as pedicle screw fixation system of the non cervical posterior r or peareliar assort when matients, these systems are indicated for one or more of the following: decenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with m automory wollisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass. The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment. When used as non pedicular fixation system: The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following: - Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic . origin with degeneration of the disc confirmed by history and radiographic studies). - Spondylolisthesis . - Fracture . - Spinal deformities such as scoliosis, kyphosis, lordosis . - . Tumor - Revision of failed fusion attempts . - Pseudoarthrosis . - Spinal Stenosis . When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.

The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the form of side to side, axial connectors, and offset connectors with various length arms up to 35mm. Additionally, pre bent 6.0 mm diameter rods, in various lengths, will be provided to be used with the side to side connectors, if required. These connectors are intended to be used with 5.5 mm, 6.0 mm, and 6.35 mm diameter rods. These additional components are to be used in the posterior non-cervical spine (T1-S1). The indications for use are not affected by the addition of these components.

The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Trauma (including fractures). - Tumors - Deformities or curvatures (including kyphosis, lordosis or scoliosis) - Pseudoarthrosis - Failed previous fusion - Spondylolisthesis - Spinal Stenosis THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS. WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

The REGENT Anterior Cervical Plate System is composed of various cervical plates and screws made from a Titanium alloy (Ti-6Al-4V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF. When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft. For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).

The PATHWAY ACIF is a cervical interbody fusion active as identification markers for the (Polyetheretherketone). The device continues of the implant both intra-operatively and postoperatively. The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a The device is trapezondan in hatale and is pro naiss a central cavity which is to be packed with width of 15 mm, and 13 mm in length This abouts of Indusis (0 Degree and 7 Degree and 7 Degree). The superior autograft. This device is provided in various degrees of lordos autograft. This device is provided in the resist implant migration/displacement. and inferior surfaces have serrated teeth to help resist implant migration/displacement. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The product is provided clean and "non-sterile".

The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - . Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - . Trauma (including fractures) - . Tumors - . Deformities or curvatures (including kyphosis, lordosis or scoliosis) - . Pseudoarthrosis - . Failed previous fusion - . Spondylolisthesis - Spinal Stenosis THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape. The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively. The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length. The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.