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The SpineWorks Anterior Lumbar Device 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). SW ALD Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SW ALD Interbody System implants are to be used with supplemental fixation. Patients should have at least six (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 SpineWorks Anterior Lumbar Device (SW ALD) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. SW ALD implants are available in two lordotic configurations (6° and 11°) of various heights and widths to restore lumbar lordosis and the associated sagittal balance. SW ALD implants have three tantalum x-ray markers. The SW ALD device is single-use only. Materials: Medical grade PEEK (ASTM F2026) machined from Vestakeep i4R extruded bar stock (Evonik Polymers Technologies GmbH, FDA master file MAF #1922). Medical grade tantalum (ASTM F560-08) was used to fabricate the radio opaque markers. Function: SW ALD devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

The A-Wedge Anterior Interbody 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 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). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior or anterolateral approach. The Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of nonoperative 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 A-Wedge Anterior Interbody System (A-Wedge A.I.S.) implants were developed as implants for the posterior stabilization of the lumbar spinal column. The body is rounded trapezoidal in shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surface of the device has a pattern of teeth to provide increased stability and inhibit movement of the implant.

The SpineWorks FixxSure Cross Link is intended work with the Talon Pedicle Screw system 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The SpineWorks FixxSure Cross Link must be used with the Talon Pedicle Screw system.

The SpineWorks FixxSure Cross Link allows spinal surgeons to convert a dual-rod construct into a frame and increase overall construct strength. The FixxSure Cross Link comes in a multi-span and fixed design, both of which can be rigidly locked onto a dual-rod construct and has the capability of being manipulated into various planes of angulation. The SpineWorks implant has a proprietary dual locking mechanism allowing maximum Cross Link/rod connection while offering superior ease of insertion/use.

The Stansion Matrix™ ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.

The device is a single piece titanium VBR that is open on all sides to maximize bone ingrowth. It is available in three sizes. The device is implanted via the posterior approach, according to similar methods as the predicates. An insertion tool is provided with the device to facilitate its implantation.