# K011406: Spinal Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Dec 27, 2001 after 233 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
No predicates in its family tree.
2,048 later devices descend from it; 3 cite it directly.
2 of 2,049 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K021791: Verte-Stack Spinal System (2002), 2,047 descendants of its own
- 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

## Indications for use
The Medtronic Sofamor Danek SPINAL MESH™ System is for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. The SPINAL MESH™ device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K011406
Methodology: https://510kreport.com/methodology