# K040422: Modification to Verte-Stack

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Mar 19, 2004 after 30 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.
1,002 later devices descend from it; 3 cite it directly.
1 of 1,012 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 2.

## Most influential descendants
- 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
- K082342: Modification to Capstone Spinal System (2008), 716 descendants of its own
- K082732: Modification to: Capstone Spinal System (2008), 710 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, the 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/K040422
Methodology: https://510kreport.com/methodology