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The Whistler Modular Pedicle 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 or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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.

The Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.

The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

The Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.