# K021791: Verte-Stack Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 26, 2002 after 87 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: 2 generations back to K003155 (2001). 6 ancestors in all.
2,047 later devices descend from it; 12 cite it directly.
2 of 2,054 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001)
- K001340: Stackable Cage System, Depuyacromed (2000)
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 1.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 1.
- K011406: Spinal Mesh System, Medtronic Sofamor Danek, Inc. (2001)

## Most influential descendants
- K023570: Modification to Verte-Stack Spinal System (2002), 1,383 descendants of its own
- K031780: Verte-Stack Spinal System (2003), 1,326 descendants of its own
- K033109: Ellys and Aurys Vertebral Body Replacements (2004), 1,218 descendants of its own
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own
- K030601: Verte-Stack Spinal System (2003), 1,151 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 (Tl-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 I1 Anterior Fixation System, Titanium DYNALOKTM CLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON0 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/K021791
Methodology: https://510kreport.com/methodology