# K111469: Staxxsd System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Jul 19, 2011 after 53 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: 10 generations back to K003155 (2001). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052670: Staxx XD System, Spine Wave, Inc. (2006) Summary page 1.
- K090315: Staxx XD System, Spine Wave, Inc. (2009) Summary page 1.
- K101288: Staxx XD System, Spine Wave, Inc. (2010) Summary page 1.
- (no number) StaXx® XD System: named in the summary without a submission number

## Indications for use
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx RXD System is the CapSure PS Spine System.

Source page: https://510kreport.com/device/K111469
Methodology: https://510kreport.com/methodology