# K101288: Staxx XD System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Sep 10, 2010 after 126 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003155 (2001). 30 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090315: Staxx XD System, Spine Wave, Inc. (2009) Summary page 2.

## Most influential descendants
- K102315: Staxx XDL System (2011), 3 descendants of its own
- K133207: Staxx (R) System (2013), 1 descendant of its own
- K142996: StaXx (R) XD System (2015), 0 descendants of its own
- K140563: Lateral VBR System (2014), 0 descendants of its own
- K111469: Staxxsd System (2011), 0 descendants of its own

## Recalls of this device
- Oct 22, 2010 · Not classified · Z-0967-2011: Package Insert Incorrect

## Indications for use
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L-5) 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® XD System is the CapSure® PS Spine System.

Source page: https://510kreport.com/device/K101288
Methodology: https://510kreport.com/methodology