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The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3): - · Traumatic spinal fractures and/or traumatic dislocations - · Instability or deformity - · Failed previous fusions (e.g. pseudarthrosis) - · Tumors involving the cervical/thoracic spine - · Degenerative disease, including intractable radiculopathy and/or myelopathy - · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies - · Degenerative disease of the facets with instability The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.

The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion. The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.

The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the following acute and chronic instabilities or deformities: · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Pseudoarthrosis; - · Spondylolysis: - · Spondylolisthesis; - · Spinal stenosis; - · Tumors; - · Trauma (i.e. Fractures or Dislocation); - · Deformities (i.e. Scoliosis, Kyphosis or Lordosis); - · Failed Previous Fusion

The MiRus MoRe Lumbar Plating System is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the lumbar spine following lumbar interbody fusion. The MiRus MoRe Lumbar Plating System consists of implants manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, screws and locking cam mechanism manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The MiRus MoRe Lumbar Plating System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements: ANTARES" Anterior Lumbar Plate and MiRus Lateral Lumbar Plate. The plates are provided sterile packed and are intended for single use only. The screws must be steam sterilized prior to use.

The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.

The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an integrated anterior cervical interbody fusion device used to provide structural stability following discectomy. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System consists of cages additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking cams manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System implants are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches. The interbodies are provided sterile packed and are intended for single use only. The bone screws must be steam sterilized prior to use.

The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy. The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.

The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device. When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.

The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a spinal intervertebral body fusion device used to provide structural stability following lateral lumbar interbody fusion for lumbar degenerative disorders. The MiRus 3DR LLIF is additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001. The MiRus MoRe Lateral Lumbar Plating System consists of a lateral plate manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, bone screws, locking cam mechanism, and a connecting screw manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. Instrumentation is manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain with degeneration of disc confirmed by patient history and radiographic studies); (2) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors: (7) Pseudoarthrosis: (8) Failed previous fusions.

The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis used to provide structural stability following anterior cervical discectomy and fusion for cervical degenerative disorders. The CYGNUS™ MoRe Anterior Cervical Plate System consists of implants manufactured from Wrought Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use: - · In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1) - · In patients having have received 6 months of nonoperative treatment prior to treatment - With or without screws - · With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft Standalone Use (with screws) ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used. Use with Supplemental Fixation (with or without screws) ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis). When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an integrated anterior lumbar interbody fusion device used to provide structural stability following discectomy. The system consists of an interbody cage additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking mechanism manufactured from Titanium-6 Aluminum-4 ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System cages are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

The IO™ Expandable Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The IO™ Expandable Lumbar Interbody Fusion System is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The IO™ Expandable Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (ASTM F136). Expansion mechanism components and the drive screw are manufactured from molybdenum rhenium (MoRe) alloy (ASTM F3273). The system is offered in various sizes to accommodate different patient anatomy requirements. Implants will be provided sterile and are intended for single use only.

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

The RIGEL™ 3DR (3D-printed Randomized-lattice) Anterior Cervical Interbody Fusion System consist of implants manufactured from Titanium 6AL-4V ELI per ASTM F3001-14 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Device is offered in various footprints, heights, and lordosis to accommodate different patient anatomy and the Anterior Cervical Surgical Approach. The implants will be provided sterile and are intended for single use only.

The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001-14 and are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed; Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants are provided sterile and are intended for single use only.