# K173125: T2 STRATOSPHERE™ Expandable Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 20, 2017 after 82 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: 12 generations back to K003155 (2001). 41 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100976: T2 XVBR 1.5 Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 4.
- K083186: Aesculap Hydrolift VBR System, Aesculap Implant System, Inc. (2010) Summary page 4.
- K071033: T2 XVBR Spinal System, Medtronic Sofamor Danek (2007) Summary page 4.
- K052931: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2005) Summary page 4.

## Most influential descendants
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 descendants of its own
- K183510: T2 STRATOSPHERE Expandable Corpectomy System (2019), 27 descendants of its own
- 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
- K191039: Navigated T2 STRATOSPHERE Inserters and Navigated Templates (2019), 18 descendants of its own

## Indications for use
The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar 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 thoracolumbar spine. 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 thoracolumbar 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/K173125
Methodology: https://510kreport.com/methodology