# K061938: Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Aug 9, 2006 after 30 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.
152 later devices descend from it; 1 cites it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060719: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2006) Summary page 2.
- K052931: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- K030736: Verte-Stack Spinal System, Extra Small Sizes, Medtronic Sofamor Danek (2003) Summary page 2.

## Most influential descendants
- K062427: Verte-Stack Spinal System (2006), 151 descendants of its own
- K070742: Modification to Vertex Reconstruction System (2007), 150 descendants of its own
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System (2011), 106 descendants of its own
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own

## Indications for use
The VERTE-STACK® Spinal System is a vertebral body replacement device 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 VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE 1I Anterior Fixation System, DYNALOK TM CLASSIC Spinal System, the VANTAGE TM Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K061938
Methodology: https://510kreport.com/methodology