The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ASTM F-136. The ST360° Spinal Fixation System is a spinal rod, screw and hook system. This system’s polyaxial and fixed screws, hooks, and connectors can be rigidly locked into a wide range of configurations, therefore, allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature. Torque limiting instruments are designed to deliver a preset torque value when rotated in the clockwise direction. When the preset torque value is reached the instrument is designed to release. The handle will rotate approximately 30 degrees and the instrument is then reset to deliver the preset torque value again.

The ST360°® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation for the following indications: 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients. When used as a hook and sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of theST360° Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Contraindications of the ST360° Spinal Fixation System are similar to other commercially available posterior spinal fixation systems of similar design and material. Contraindications include but are not limited to the following:

• Use in the cervical spine
• Active systemic or local infection
• Obesity
• Pregnancy
• Mental illness
• Severe osteoporosis or osteopenia
• Metal sensitivity/allergies to the implant material
• Alcohol or drug abuse
• Patients are unwilling or unable to follow postoperative instructions
• Soft tissue deficit not allowing wound closure
• Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
• Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
• Any medical or mental condition which would exclude the patient or put the patient at high risk from surgery of this severity
• For pedicle screw cases, inadequate pedicles of the thoracic, lumbar, and sacral vertebrae

The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary due to 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, deformities or curvatures, (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients. The safety and effectiveness of these devices for any other conditions are unknown. Potential risks identified with the use of this system that may require additional surgery include device component fracture, loss of fixation, non-union, fracture of the vertebrae, neurologic injury, and vascular or visceral injury. The ST360° Top Loading rods are intended for single-level use only.

The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. This system should only be used with instrumentation specifically designed for this system. The ST360° Spinal Fixation System can only be used in conjunction with the components from the Silhouette Spinal System®. Components of competitive spinal fixation systems should not be used with components of the ST360° Spinal Fixation System due to the potential for accelerating the corrosion process by the mixing of dissimilar materials. No component of the ST360° Spinal Fixation System should be reused after being removed from the body. An implant should never be re-sterilized after contact with body tissue or body fluids. All implants and some instruments are intended for single use only; refer to the product label to determine if the instrument is intended for single use only. Single use devices should not be re-used. Possible risks associated with re-use of single use devices include:

• Mechanical malfunction
• Transmission of infectious agents

  The ST360° Spinal Fixation System is intended to be used with bone graft which is required to provide additional spinal support. Use of this product without bone graft or in cases that develop into a non-union will eventually be unsuccessful. A successful result is not always achieved in every surgical case. Posterior spinal fixation systems cannot withstand body loads without the support of bone. In the event that bone is not provided to facilitate fusion, bending, loosening, disassembling, and/or breakage of the implants will eventually occur. The patients should be made aware that a successful result, as defined by reduced pain, increased function, and the establishment of solid fusion, is not always achieved in every surgical case. Proper patient selection will greatly affect the results. Patients who smoke have shown to have an increased incidence of non-union. These patients should be informed of this increased risk and counseled to discontinue tobacco use prior to and immediately after surgery. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spinal fusion. Patients with poor muscle tone and bone quality and/or nerve paralysis are also poor candidates for spinal fusion. The use of autogenous bone graft has been shown to provide superior results compared to the use of allograft bone graft material. In addition to the above specified warnings and precautions, general surgical risks should be explained to the patient prior to surgery. Torque limiting instrument adjustment screws or caps with set screws should not be manipulated during the cleaning process. Manipulation or disassembly of the instrument will affect the calibration of the instrument and it will require re-calibration prior to use.

Prior to surgery, patients should be made aware of the following possible adverse effects in addition to the potential for additional surgery to correct these effects:

• Loosening, disassembly, bending or breakage of components
• Tissue sensitivity to implant material
• Potential for skin breakdown and/or wound complications
• Non-union or delayed union
• Infection
• Nerve damage, including loss of neurologic function, dural tears, paralysis, paresthesia, and cerebral spinal fluid leakage
• Fracture of vertebrae
• Loss of fixation
• Vascular or visceral injury
• Change of normal spinal curvature
• Gastrointestinal, urological and/or reproductive system compromise
• Pain or discomfort
• Bursitis
• Decrease in bone density due to stress shielding
• Loss of bone or fracture of bone above or below the level of surgery
• Bone graft donor site pain, fracture, and/or delayed wound healing
• Restriction of activities
• Lack of effective treatment of symptoms for which the surgery was intended
• Death