SP-Fix

SP-Fix
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SP-Fix

Product catalog summary
Anatomy of the Spine
The spine consists of vertebrae divided into three main sections: Cervical (7 vertebrae), Thoracic (12 vertebrae), and Lumbar (5 vertebrae). Below the lumbar spine is the sacrum, composed of 5 fused vertebrae, and the coccyx or tailbone. Vertebrae support the upper body, provide muscle and ligament attachment points, and protect the spinal canal.

What is Degenerative Disc Disease?
Degenerative Disc Disease (DDD) involves the intervertebral disc and is part of the natural aging process. It can result from torsional injury to the lower back, leading to pain and instability. Symptoms include back or leg pain, which may worsen with prolonged sitting, bending, or twisting.

What is Spondylolisthesis?
Spondylolisthesis is a condition where a vertebra slips forward or backward, potentially causing spinal deformity and narrowing of the spinal canal. Symptoms include low back pain, muscle spasms, and leg pain, though some patients may be asymptomatic.

How the SP-Fix™ Spinous Process Fixation System Works
The SP-Fix™ system is a fixation device for supplemental spinal fixation, supporting minimally invasive surgery. It is available in various sizes and configurations, such as Plate and Barrel Assembly or Plate Assembly, tailored to the patient's anatomy.

How is the Procedure Performed?
The procedure involves relieving pressure on the spinal cord or nerves, making an incision, and implanting the device between spinous processes. Bone graft material is used to facilitate fusion, and the system can be used with other fixation devices.

What Should I Expect with My Recovery?
Recovery varies, with many patients resuming normal activities in 2-4 weeks. A positive attitude and adherence to post-surgical instructions contribute to a successful outcome.

Contraindications, Complications, Warnings, and Precautions
Contraindications include infection, congenital abnormalities, obesity, pregnancy, mental illness, diabetes, rheumatoid arthritis, osteoporosis, or cancer. Potential complications include implant issues, non-union, pain, infection, nerve damage, and more. Consult with a surgeon for a comprehensive list and personalized advice.
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Catalog excerpts

SP-Fix-1

Patient Information SP-Fix Spinous Process Fixation System

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Table of Contents Anatomy of the Spine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is Degenerative Disc Disease?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 What is Spondylolisthesis?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 How the SP-Fix™ Spinous Process Fixation System Works. . . . . . . . . . 6 How is the Procedure Performed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 What Should I Expect with My Recovery? . . . . . . . . . . . . . . . . . . . . . . . . 8 Contraindications,...

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Spinous Process Fixation System Patient Information This brochure will help you understand more about: • General conditions of the spine • Information about surgical treatment • What to expect from surgery The decision to receive medical treatment is individualized to the patient and the patient’s symptoms. The information presented within this brochure may not apply to your condition, treatment or its outcome, as surgical techniques vary and complications can occur. It is important to discuss the viability of this procedure with your physician to decide whether this treatment option is right...

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Cervical Area Thoracic Area SP-Fix™ Patient Informatio

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Anatomy of the Spine The spine is made up of vertebrae and is divided into 3 main sections: • Cervical (7 vertebrae) • Thoracic (12 vertebrae) • Lumbar (5 vertebrae) Below the lumbar spine is the sacrum which is composed of 5 fused vertebrae. At the end of the spine is the coccyx, or the tailbone. The vertebrae bear the weight of the upper body and provide points of attachment for muscles and ligaments and also feature bones called spinous processes. Spinous processes are the bones you can feel in the middle of your back if you run your hand over your spine. Vertebrae also protect the spinal...

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What is Degenerative Disc Disease? Degenerative changes in the spine may cause instability and pain in your back. Degenerative Disc Disease (DDD) involves the intervertebral disc and is part of the natural aging process. DDD can also result from torsional (twisting) injury to the lower back. In the normal spine, your discs act as a cushion between vertebrae. Over time the discs can lose flexibility, elasticity and height. When this happens, they lose their shock absorbing characteristics and can lead to abnormal motion or alignment of the spine, which may result in pain. Symptoms of DDD include...

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What is Spondylolisthesis? Spondylolisthesis is a condition in which one of the vertebrae slips forward or backward. If left untreated, this can lead to deformity of the spine and narrowing of the spinal canal. Typical symptoms include low back pain, muscle spasms, thigh or leg pain and weakness. Interestingly, some patients are asymptomatic and only learn of the disorder after spinal radiographs. Normal spine segment Displaced vertebra causing pressure on nerve SP-Fix™ Patient Information

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Answers to your questions regarding SP-Fix Spinous Process Fixation System ™ How the SP-Fix™ Spinous Process Fixation System Works The SP-Fix™ Spinous Process Fixation System is a fixation device designed to provide supplemental fixation in your spine and supports a minimally invasive surgical technique. SP-Fix™ is available in various sizes to fit specific anatomy and comes in either a Plate and Barrel Assembly or a Plate Assembly. Your surgeon will recommend which procedure and implant is best for you and your condition. Plate and Barrel Assembly Plate Assembly

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How is the Procedure Performed? Your surgeon may need to relieve excess pressure on the spinal cord or nerves. An incision will be made in your back over the affected area. Your surgeon will implant the device into your spine between your spinous processes. Once the device has been implanted, your surgeon will clamp the implant together, locking it to your spinous processes. Bone graft material is placed around the final assembly to facilitate fusion. SP-Fix™ is designed to be used with other fixation devices such as pedicle screws, facet screws or an interbody device with a plate and screw along...

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What Should I Expect with My Recovery? Treatment with SP-Fix™ Spinous Process Fixation System may help you return to normal activities. Many patients recover in 2–4 weeks; however, recovery time varies between patients. Some patients may be able to get out of bed the day of surgery and may be discharged the following day. A positive attitude, reasonable expectations and compliance with your doctor’s post-surgical instructions may all contribute to a satisfactory outcome. SP-Fix™ Patient Info

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Contraindications, Complications, Warnings, and Precautions You may be contraindicated for this device if you have an infection, a congenital abnormality, are obese, pregnant, mentally ill, diabetic, suffer from rheumatoid arthritis, osteoporosis, or cancer. As with any surgical procedure, complications may occur following the placement of this device. These can include but are not limited to early or late implant bending, breakage, failure, loosening, movement/migration, bone fracture, and allergic reaction to implant material. Other general complications associated with any spinal surgical...

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Globus Medical Valley Forge Business Center 2560 General Armistead Avenue ©2011 Globus Medical. All rights reserved. Patents pending. Life moves us is a registered trademark of Globus Medical. SP-Fix is a trademark of Globus Medical. Caution: Federal (USA) Law Restricts this Device to Sale by or on the Order of a Physician. 8.11

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.