# K040167: Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Feb 18, 2004 after 23 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K063637: Reliance VBS System (2007), 1 descendant of its own
- K081383: Reliance VBS System (2008), 0 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 (T1-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 Anterior Fixation System, DYNALOK CLASSIC Spinal System, the VANTAGE 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/K040167
Methodology: https://510kreport.com/methodology