# K041197: Modification to Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 9, 2004 after 94 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: 5 generations back to K003155 (2001). 9 ancestors in all.
994 later devices descend from it; 3 cite it directly.
1 of 1,004 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K052931: Modification to Verte-Stack Spinal System (2005), 993 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
- K082732: Modification to: Capstone Spinal System (2008), 710 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 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, 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/K041197
Methodology: https://510kreport.com/methodology