# K063491: T2 Sceptor Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Mar 5, 2007 after 108 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: 9 generations back to K003155 (2001). 18 ancestors in all.
53 later devices descend from it; 2 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)
- K052931: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- K060719: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2006) Summary page 2.
- K011406: Spinal Mesh System, Medtronic Sofamor Danek, Inc. (2001) Summary page 2.

## Most influential descendants
- K091883: T2 Spinal System (2009), 51 descendants of its own
- K071033: T2 XVBR Spinal System (2007), 50 descendants of its own
- 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

## Indications for use
The T2TM SCEPTORTh Spinal System is a vertebral body replacement device 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 SCEPTORTM Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTORTh device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOKTM CLASSIC Spinal System, the VANTAGETM Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2TM SCEPTORTh device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K063491
Methodology: https://510kreport.com/methodology