# K183510: T2 STRATOSPHERE Expandable Corpectomy System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jan 16, 2019 after 29 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K003155 (2001). 115 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 5.
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System, Medtronic Sofamor Danek (2017) Summary page 5.
- K071033: T2 XVBR Spinal System, Medtronic Sofamor Danek (2007) Summary page 5.

## Most influential descendants
- K191066: CD Horizon™ Astute™ Spinal System (2019), 21 descendants of its own
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own

## Indications for use
Cervical and Thoracolumbar 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 autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft 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 bone graft used at the surgeon’s discretion. The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable 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. The T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft, 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K183510
Methodology: https://510kreport.com/methodology