# K041452: Modification to Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 24, 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
Longest line of descent: 5 generations back to K003155 (2001). 10 ancestors in all.
815 later devices descend from it; 4 cite it directly.
1 of 826 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.
- K030735: Modified Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- 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
- K090353: Perimeter Interbody Fusion Device (2009), 796 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K043566: Modification to Verte-Stack Spinal System (2005), 726 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K082342: Modification to Capstone Spinal System (2008), 716 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, the 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/K041452
Methodology: https://510kreport.com/methodology