T2 Stratosphere™ Expandable
M708348B801E Rev. C
Corpectomy System (Cervical and
Thoracolumbar)
2020-03-25
IMPORTANT INFORMATION ON THE T2 STRATOSPHERE™ EXPANDABLE
CORPECTOMY SYSTEM (CERVICAL AND THORACOLUMBAR)
PURPOSE
The T2 Stratosphere™ Expandable Corpectomy System is intended for vertebral body replacement to aid in the surgical
correction and stabilization of the thoracolumbar and cervical spine.
DESCRIPTION
The T2 Stratosphere™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a selfadjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient’s anatomical
requirements. T2 Stratosphere™ Expandable Corpectomy System devices for use in the thoracolumbar and cervical spine are
restricted to the 13mm diameter centerpieces. The T2 Stratosphere™ Expandable Corpectomy System is manufactured from
titanium alloy and is provided sterile and non-sterile. This device is inserted between two vertebral bodies in the thoracolumbar
or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available
in multiple heights. The system also features modular end caps which are available in various angles and diameters, and are
only for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.
For Thoracolumbar Corpectomy with an Expandable Device
The device may be implanted through a lateral, oblique, or posterior approach using a minimally invasive technique or implanted
through a lateral, oblique, posterior, or anterior approach through a traditional open technique. The device is indicated for single
or two-level use in the thoracic and lumbar anterior spine.
The T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the
thoracolumbar spine.
For Cervical Corpectomy with an Expandable Device
The device may be implanted through an anterior approach using a traditional open technique.
The T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the
cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation.
Do not use implant components from any other manufacturer with T2 Stratosphere™ Expandable Corpectomy System
components. Never use titanium or titanium alloy implants with stainless steel in the same construct. No warranties, express or
implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
INDICATIONS
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic
and lumbar spine (T1-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for
use in skeletally mature patients.
When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed,
damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following
corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When
used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end
caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is
intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental
fixation should include posterior fixation cleared for use in the cervical spine.
When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a
collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable
Corpectomy centerpiece may be used with or without optional modular end caps which accommodate individual anatomic
requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine.
When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous
bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft
bone with bone marrow aspirate as an adjunct to fusion. When used in the thoracic and lumbar spine, the T2 Stratosphere™
Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. The
T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in
whom life expectancy is of insufficient duration to permit achievement of fusion, with autogenous bone and/or allograft bone
graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate used at the surgeon’s discretion.
CONTRAINDICATIONS
The device is not intended to be implanted from a posterior cervical approach. Contraindications include:
▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence
of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count
(WBC), or a marked left shift in the WBC differential count.
▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Any non-tumor cases where a bone graft and fusion are unnecessary or where fracture healing is not required.
▪ Any time implant use would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ Infection (excluding osteomyelitis in the cervical spine) local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Suspected or documented metal allergy or intolerance.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
Contraindications of this device are consistent with those of other spinal systems.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.
POSSIBLE ADVERSE EVENTS
All adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:
▪ Early or late loosening of components and implant migration.
▪ Disassembly, bending, and/or breakage of any or all components.
▪ Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining, tumor formation
and/or autoimmune disease.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and meningitis.
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
arachnoiditis, and/or muscle loss.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Urinary retention,loss of bladder control, or other types of urological system compromise.
▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Subsidence of the device into vertebral body(ies).
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Loss of spinal mobility or function.
▪ Inability to perform activities of daily living.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the bone graft, or at the
bone graft harvest site at, above, and/or below the level of surgery.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
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