# K043566: Modification to Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jan 7, 2005 after 11 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: 6 generations back to K003155 (2001). 11 ancestors in all.
726 later devices descend from it; 2 cite it directly.
1 of 738 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041452: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- 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
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 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-STACK device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK CLASSIC Spinal System, the VANTAGE TM Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACKT device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K043566
Methodology: https://510kreport.com/methodology