Category: Thoracolumbar Fixation
The EXPEDIUM® 5.5 System is an innovative spine solution that provides technological advancements to treat a range of spinal pathologies. The EXPEDIUM Spine System offers a comprehensive solution for rigid posterior fixation of the thoracolumbar regions of the spine. Please note that DePuy Synthes Companies also offer the EXPEDIUM 6.35 System, a stand alone pedicle screw fixation system that is part of the EXPEDIUM Spine System family, offering similar clinical benefits to surgeons and patients. EXPEDIUM 6.35 System is ideal for use when a larger rod diameter is needed.
The EXPEDIUM Spine System is a hook, rod and screw system comprised of a variety of implant options including:
– Polyaxial, Uniplanar, Monoaxial, and Reduction Pedicle Screws
– Hooks, Cables and Wires
– Spinal Rods in Titanium (Alloy and Commercially Pure), Cobalt Chromium Alloy, and Stainless Steel (Standard, High and Ultra Strengths)
Through unique design innovations, the EXPEDIUM Spine System combines simplicity and versatility allowing the surgeon to design the construct based on intraoperative developments and individual patient anatomy.
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.
Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
WARNING: 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 L5S1 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.
PRECAUTION: 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.
The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device.
WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.
Please refer to the package insert for a complete list of indications, contraindications, precautions and warnings.
For further information on DePuy Synthes products, please contact your local DePuy Synthes representative.
|TOP NOTCH® Feature||Secure, Inline Instrument attachment
|Smart Screw Design||Eliminates need to tap
Accelerates bone purchase
Decreases insertion time
Helps to ensure accurate insertion/trajectory
|Square Thread Closure
Reduces cross threading
Minimizes head spread
|Dual Innie Independent
|Converts a polyaxial to a monoaxial screw intraoperatively
Achieves true parallel compression and distraction during TLIF and
burst compression fracture Procedures
|Multiple Options for
Open and closed iliac screws, fixed and angulating lateral connectors and
TOP NOTCH® Feature
Smart Screw Design
Square Thread Closure
Dual Innie Independent
Multiple Options for