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The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). - Spondylolisthesis - Trauma (i.e. fracture or dislocation). - Spinal Stenosis - Deformities or curvatures (i.e scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The neoWave LS Porous Titanium Cage 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 L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The neoWave C Porous Titanium Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion. When used as a Cervical Interbody Fusion device, Ti3D Cervical is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Xenix Medical neoWave LS Lumbar Straight Cages are intervertebral body fusion devices intended for use in the lumbar spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 6-17mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. Xenix Medical neoWave C Cervical Cage is intervertebral body fusion device intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. Xenix Medical Ti3D Cervical Cages are intervertebral body fusion devices intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint ● disruptions - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.