# K030601: Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Mar 25, 2003 after 28 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.
1,151 later devices descend from it; 4 cite it directly.
1 of 1,160 devices in its family (counting itself) has 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
- K040536: Modification to Verte-Stack Spinal System (2004), 1,150 descendants of its own
- K041556: Modification to Verte-Stack Spinal System (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
- K062073: Verte-Stack Spinal System (2006), 844 descendants of its own

## Indications for use
The VERTE-STACKTM 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-STACKTM Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACKTM device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOKTM CLASSIC Spinal System, the VANTAGETM Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZONB Spinal System, the Titanium GDLHB Spinal System, or their successors. Additionally, the VERTE-STACKTM device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K030601
Methodology: https://510kreport.com/methodology