# K043561: Modification to Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 29, 2004 after 2 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: 7 generations back to K003155 (2001). 13 ancestors in all.
999 later devices descend from it; 2 cite it directly.
1 of 1,013 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041556: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K040422: Modification to Verte-Stack, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K060719: Modification to Verte-Stack Spinal System (2006), 992 descendants of its own
- K062073: Verte-Stack Spinal System (2006), 844 descendants of its own
- K082342: Modification to Capstone Spinal System (2008), 716 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 TM 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, the Titanium DYNALOKTM CLASSIC Spinal System, the VANTAGE TM Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-STACK TM device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K043561
Methodology: https://510kreport.com/methodology