Polaris? 5.5 Spinal System

Helical Flange^? Technology

Minimizes Cross Threading: Upon initial contact, the upward and downward oriented thread lips easily align and guide the threads together, thus minimizing cross threading.

Minimized Seat Splay: Final torquing directs the forces across the upward and downward oriented thread lips in an inward fashion to significantly minimize seat splay.?

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Helical Flange is a registered trademark of Roger P. Jackson.

Product Description

The Polaris Spinal System is a spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) Rods per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, washers, staples, dominoes and various cross connectors. Various instruments are also available as part of the Polaris Spinal System for use by the surgeon to facilitate implantation of the device.

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Indications for Use

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft?and/or allograph. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista Instruments are intended to be used with the 5.5 Polaris implants. The Ballista Instruments, when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The AccuVision Instruments, when used with the Polaris Spinal System are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system.

Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The AccuVision Illuminated Blade Tip is intended for the illumination of surgical procedures and exclusively for use with the AccuVision retractor frame.

The dominoes in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet^? Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system’s Package Insert for a list of the indications for use for each system.

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery and is intended for use as part of either a single or double rod assembly. It allows for distraction at a central location once bone anchors have been secured.

The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.

The AccuVision Illuminated Blade Tip is a sterile, single use, latex free, plastic fiber optic device intended to bring cool area lighting into spinal surgeries. The AccuVision Illuminated Blade Tip is intended for use with a 300 watt xenon illuminator, using a 3mm fiber optic cable with a female ACMI connector.

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Contraindications

1. Spinal infection or inflammation
2. Morbid obesity
3. Mental illness, alcoholism or drug abuse
4. Pregnancy
5. Metal sensitivity/foreign body sensitivity
6. Patients with inadequate tissue coverage over the operative site
7. Open wounds local to the operative area
8. Any case not described in the specific indications

The AccuVision Blade Tips present no additional contraindications. The user should be familiar with the use of light sources and cables and should take precautions accordingly.

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Warnings

1. 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 to 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 safety and effectiveness of these devices for any other conditions are unknown. Potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
2. Implant Strength and Loading. The Polaris Spinal System is intended to assist healing and is not intended to replace normal bony structures. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. These devices are not designed to withstand the unsupported stress of full weight bearing or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bone. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue.
   
   Therefore, it is important that immobilization of the operative site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The surgeon must be thoroughly knowledgeable in the medical, surgical, mechanical and metallurgical aspects of the Polaris Spinal System. Postoperative care is extremely important. The patient should be warned that noncompliance with postoperative instructions could lead to breakage of the implant and/or possible migration requiring revision surgery to remove the implant.
3. Selection of Implants. Selection of the proper size, shape and design of the implant increases the potential for success. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants.
4. Corrosion. Contact of dissimilar metals accelerates the corrosion process, which could increase the possibility of fatigue fracture of the implants. Therefore, only use like or compatible metals for implants that are in contact with each other. Never use stainless steel and titanium implant components in the same construct. Cobalt Chrome Alloy rods should not be used with Stainless Steel Components. Cobalt Chrome Alloy rods are to be used ONLY with titanium implant components in the same construct.
5. Sterile Packaging. The AccuVision plastic components are packaged sterile as a single use device. Do not re-sterilize for reuse.
6. Light Source. The AccuVision Illuminated Blade Tip is designed for use with 300 watt xenon illuminators, using a 3mm fiber optic cable. Do not use light sources rated higher than 300 watts, or cables with fiber optic bundles of more than 3mm diameter. Use of higher watt sources or larger diameter cables could result in overheating; causing product failure and patient injury. Should the blade assembly become cut, collect fluid inside, appear broken or damaged in any manner, it should be replaced to minimize risk to the patient.
   
   Do not operate the light source and cable without the light strip attached. Without the AccuVision Illuminated Blade Tip, the output from the fiberoptic cable is extremely bright, hot and may cause burns, ignite drapes/gowns, or temporarily blind vision.
7. The Polaris Spinal System has not been evaluated for safety and compatibility in the MR environment and has not been tested for heating or migration in the MR environment.

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Precautions

1. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant/device. Do not treat patients with implants/devices that have been even momentarily placed in or used on a different patient.
2. Handling of Implants. If contouring of the rod is required, avoid sharp bends and reverse bends. Avoid notching or scratching of the device, which could increase internal stresses and lead to early breakage.
3. Implant Removal After Healing. After healing is complete, the implant is intended to be removed since it is no longer necessary. Implants that are not removed may result in complications such as implant loosening, fracture, corrosion, migration, pain or stress shielding of bone, particularly in young, active patients. Implant removal should be followed by adequate postoperative management.
4. Adequate Patient Instructions. A patient must be instructed on the limitations of the metallic implant, and should be cautioned regarding physical activity and weight bearing or load bearing prior to complete healing.
5. Surgical Techniques. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of pedicle screw spinal systems because this is a technically demanding procedure presenting a risk of serious injury to the patient. Please refer to the specific surgical technique for this device for more information.
6. Illuminated Blades. Light sources vary widely in emission of visible and infrared energy. As a precautionary measure, when using AccuVision Illuminated Blade Tips we recommend occasionally monitoring connector temperature during first time use with a new light source or lamp; thereafter if needed. As is common with fiber optic equipment, metal portion of connector can become hot to the touch. Use plastic grip as handle. Do not place the metal ring portion of connector directly on the patient’s skin. After use, the AccuVision Blade Tips may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

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Possible Adverse Effects

1. Nonunion (pseudarthrosis) or delayed union
2. Loss of fixation or bending, fracture, loosening or migration of the implant or instruments
3. Metal sensitivity or foreign body reaction, including possible tumor formation, skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications
4. Decrease in bone density due to stress shielding
5. Pain, discomfort, or abnormal sensations due to presence of the implant
6. Nerve, soft tissue, or blood vessel damage due to surgical trauma including loss of neurological function, dural tears, radiculopathy, paralysis and cerebral spinal fluid leakage,
7. Gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency and/or loss of consortium
8. Fracture of bony structures at, above or below the level of surgery (fracture of the vertebra),
9. Nerve root or spinal cord impingement
10. Bursitis
11. Necrosis of bone
12. Hemorrhage of blood vessels and/or hematomas
13. Malalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height
14. Bone graft donor site pain
15. Inability to resume activities of normal daily living
16. Neurological, vascular or visceral injury
17. Reoperation
18. Infection
19. Death