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The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of rods, pedicle screws, connectors and fasteners. Rods are available in either straight, or pre-contoured (curved) or revision forms in a variety of lengths. Pedicle screws are available in modular and non-modular polyaxial, and non-modular uniplanar designs having double lead standard or cortical/cancellous thread forms in a variety of diameter-length combinations. Connectors include offset, various wedding band options and transverse rod-to-rod. Set screws are used to fasten the components. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants may be sold sterile or nonsterile.

The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (TI-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediative patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allografi. Pediatric pediatic pediatic pediatic pediatic pediatic pediatic pedicle screw fixation is limited to a posterior approach.

The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of longitudinal members (rods), anchors (pedicle screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants are sold sterile and non-sterile.

The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal 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, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The NEXXT SPINE NAVIGATION System is an instrumentation system which includes taps and a probe, an awl and an inserter. The devices are used in conjunction with the Medtronic® StealthStation Navigation System to assist with placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The instruments are sold non-sterile and are reusable.

The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels and should have received at least six months of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation.

NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone ALIF System includes additively manufactured interbody and traditionally machined fixation screw implants. The interbody and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the interbody is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have 300-700µm pores. The inferior/superior aspects of the interbody incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with turn lock mechanisms which secure the screws to the interbody component.

The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery. The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The STRUXXURE®-L and STRUXXURE®-A Plate System is a lumbar plate and screw system. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold non-sterile.

When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc 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 radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® ALIF and Lateral devices incorporate a large vertical cavity which can be packed with bone graft material. The devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical-TL System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be used with the bone screw fixation provided and requires no additional fixation.

NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical-TL System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7 µm). The intervening geometric lattices have 300-700um pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with a turn lock mechanism which secures the screw to the spacer component.

The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc 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 radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

When used as a lumbar intervertebral fusion device, TrellOss™-L MPF is indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc 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. Additionally, TrellOss™-L MPF can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. TrellOss™-L MPF is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation. TrellOss™-L MPF interbody implants with 14° lordosis or greater are only indicated for lumbar levels L2-L5 and are to be used with at least a 1-hole Timberline® MPF plate and screw construct.

TrellOss™-L MPF is a 3D printed, lateral interbody fusion device. The inferior/superior aspects of the TrellOss™-L MPF interbody incorporates two large vertical cavities which can be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft material. Each interbody comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700μm. The TrellOss™-L MPF interbody can be used in conjunction with the Timberline® MPF plates and screws. The plate implants are offered having 1-, 2-, 3- or 4-holes to accommodate the vertebral screws. Cover plates secure the construct. TrellOss™-L MPF interbody implants are provided sterile while the Timberline® MPF plate and screw implants are provided non-sterile. All devices are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient.