# K100976: T2 XVBR 1.5 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 21, 2010 after 196 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: 11 generations back to K003155 (2001). 37 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071033: T2 XVBR Spinal System, Medtronic Sofamor Danek (2007) Summary page 2.
- K082112: T2 XVBR Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K091883: T2 Spinal System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 2.

## Most influential descendants
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System (2017), 47 descendants of its own
- 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

## Indications for use
The T2 ALTITUDE™ 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 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.

Source page: https://510kreport.com/device/K100976
Methodology: https://510kreport.com/methodology