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The EXPEDIUM® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The EXPEDIUM® Spine System is intended for noncervical pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pediatic patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scolosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The EXPEDIUM VERSE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformites of the thoracic, lumbar and sacral spine. The EXPEDIUM VERSE® System is intended for noncervical pedicle fixation and nonpedicle fixation 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM VERSE® System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE® System metallic implants are indicated as an adjunct to fusion to treat progressive spinal deformities (1.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the EXPEDIUM VERSE® system is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems consists of metallic implants intended to provide immobilization and stabilization of spinal segments. The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems also consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.

When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1) The CONFIDENCE™ High Viscosity Spinal Cement is a self-curing, high viscosity, radiopaque acrylic bone cement (PMMA), previously cleared by FDA in premarket notifications K060300 and K112907. The formulation of the spinal cement has not changed from the original clearance. 2) The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).