T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM INDICATIONS
Cervical (C2-C7) - 13mm Centerpieces Only
The T2 Stratosphere™ Expandable Corpectomy System is used in skeletally mature patients 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. The T2 Stratosphere™ System is also intended for patients with advanced stage tumors in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The device is intended to be used with supplemental fixation and when used at more than two levels supplemental fixation should include posterior fixation. The T2 Stratosphere™ System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.
Thoracolumbar (T1-L5) - All Implants
The T2 Stratosphere™ Expandable Corpectomy System is used in skeletally mature patients to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ System is also intended for patients with advanced stage tumors in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The device is to be used with supplemental fixation. The T2 Stratosphere™ System is intended for use with autograft or allograft as an adjunct to fusion.
Note: T2 Stratosphere Navigation is for the Thoracolumbar Spine only.
RISKS
A successful result is not always achieved in every surgical case. Potential risks associated with the device include, but are not limited to:
- Subsidence, implant migration, or vertebral body fracture
- Tissue damage, nerve damage, or loss of neurological function
- Implant loosening, breakage, fracture, or debris
- Postoperative change in spinal curvature, loss of correction, height, and/or reduction
- Site complications including pain, infection, or wound healing problems
