# K091883: T2 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 21, 2009 after 89 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: 10 generations back to K003155 (2001). 20 ancestors in all.
51 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082112: T2 XVBR Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K063491: T2 Sceptor Spinal System, Medtronic Sofamor Danek (2007) Summary page 2.

## Most influential descendants
- K100976: T2 XVBR 1.5 Spinal System (2010), 49 descendants of its own
- 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

## Indications for use
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), The T2TM XVBR system consists of end caps which must be attached to a T2 XVBRTM expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTORTM components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTORTM end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBRTm and T2 SCEPTOR TM ) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE iFM Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE TM Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended-to be used with allograft and/or autograft.

Source page: https://510kreport.com/device/K091883
Methodology: https://510kreport.com/methodology