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The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.

The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

The VertiFlex® Direct Decompression System consists of a group of instruments intended to assist in the performance of lumbar decompression through a minimallyinvasive approach. The instruments include both reusable, and single-use disposable devices. In combination, these instruments include dilators and a cannula through which the user may gain access to the site of decompression, and several specialized instruments with which both bony and soft tissue may be removed to decompress the neural elements. The single-use disposable devices will be provided sterile, and the reusable devices will be provided non-sterile for sterilization by the user before use.

When used as a vertebral body replacement: The Octane™ device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral book due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spiral oord ard neural tissues, and to restore the height of a collapsed vertebral body. The Schnal Corner Tor device 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. The Octane™ device may be used with allograft or autograft. When used as an intervertebral body fusion device: The Octane™ device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The Octane™ device is intended to be used with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Like the predicate Octane™ Vertebral Body Replacement System, or Octane™ VBR System, the Octane™ device that is the subject of this "Special" 510(k) submission is an implant composed of pure Poly(Etheretherketone), or PEEK OPTIMA®, Grade LT1, When used as a vertebral body replacement, the device is intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). When used as an intervertebral body fusion device, the device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). As a vertebral body replacement, the device is intended for use with allograft or autograft, and as an intervertebral body fusion device, it is intended for use with autogenous bone graft. Octane™ implants are available in a range of sizes and shapes, to accommodate different surgical approaches and anatomical needs, and may be implanted by cither conventional surgical methods, or via minimally-invasive techniques.

When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.

When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw System is intended 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 of the thoracic, lumbar, and sacral spine: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies; - Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; . - Degenerative spondylolisthesis; ● - Trauma (i.e., fracture or dislocation); . - . Spinal stenosis; - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); . - Tumor , . - Pseudoarthrosis; and/or . - Failed previous fusion. .

The Extended VertiFlex® Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium conforming to ASTM F67, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques, although the line extension which is a subject of this submission is designed specifically to facilitate MIS/percutaneous use. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. The modifications that are the subject of this submission consist of the addition of rod and screw components designed to more easily create multi-level constructs percutaneously, and screws having smaller diameters. Screws, rods, and instruments are offered non-sterile.