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The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.

The Reliance Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The Reliance Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). When used in a percutaneous, posterior approach with MIS instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws, staples, and set screws. The Anterior Reliance staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section) The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively. The subject Reliance Spinal Screw offers two new fenestrated screw systems (single and circumferential) for use with saline or radiopaque dye only, a percutaneous screw system, and two barend rod systems. These additions will be available in similar sizes, material and configurations as the currently approved Reliance Spinal Screws.

The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 Spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System, originally cleared by FDA in K113540, is intended to be used as an intervertebral body fusion device. Reliance Lumbar IBF device is a spacer, which inserts between vertebral bodies in the anterior column of the thoracic and lumbar spine. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The Reliance Lumbar IBF device will be manufactured from PEEK. The PEEK device also contains Tantalum wires to aid in fluoroscopic visualization. The construct is not intended to be employed as a standalone device. The Reliance Lumbar IBF is to be used with supplemental fixation in all applications.

The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer is made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System also includes bone screws to secure the device to the vertebral body.

The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implant and instrument components. The Reliance Cervical IBF, the implant component, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The Reliance Cervical IBF spacer is either comprised of PEEK Optima HA with Tantalum markers, or from PEEK Optima LT1 with Tantalum markers. The Reliance Cervical IBF-S spacer (PEEK Optima LT1 or PEEK Optima HA) also incorporates screws to better fixate and stabilize the spine. These screws are manufactured from Titanium alloy as described by ASTM F-136. The device is intended for interbody fusion in the cervical spine and to aid in the surgical correction and stabilization of the spine.

The Reliance Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis, and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar, and sacral spine. The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws. staples, and set screws. The Anterior Reliance staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section) The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK OPTIMA LT1 with Tantalum markers.

The RELIANCE Spinal Screw System is a pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe degenerative spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: degenerative spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The RELIANCE Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). When used in a percutaneous, posterior approach with MIS instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following: - ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies) - Spondylolisthesis . - Spinal stenosis • - Fracture/dislocation • - Revision of previous cervical spine surgery . - . Tumors The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4–T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.

The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs. The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.