# K031780: Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jul 30, 2003 after 50 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: 4 generations back to K003155 (2001). 8 ancestors in all.
1,326 later devices descend from it; 11 cite it directly.
2 of 1,335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023570: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.

## Most influential descendants
- K041556: Modification to Verte-Stack Spinal System (2004), 1,002 descendants of its own
- K040422: Modification to Verte-Stack (2004), 1,002 descendants of its own
- K043561: Modification to Verte-Stack Spinal System (2004), 999 descendants of its own
- K060719: Modification to Verte-Stack Spinal System (2006), 992 descendants of its own
- K040731: Stryker Spine Vertebral Spacer (2004), 895 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 II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON® Spinal System, the Titanium 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/K031780
Methodology: https://510kreport.com/methodology