# K131888: T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Sep 23, 2013 after 90 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091883: T2 Spinal System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 4.
- K100976: T2 XVBR 1.5 Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 4.

## 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 flTM components consist of end caps which must be attached to aT2 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-CtD device to form a complete construct. Both constructs (T2 XVBRTM and 12 SCEPTQRTM) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE 11I1TM Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGETM 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. The T'2 ALTITUDETM Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-1-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDETM Expandable 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®D Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDETM Expandable Corpectomy System is intended to be used with allograft and/or autograft.

Source page: https://510kreport.com/device/K131888
Methodology: https://510kreport.com/methodology