# K052670: Staxx XD System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 27, 2006 after 212 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: 7 generations back to K003155 (2001). 28 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043566: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.
- K041939: Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers, Blackstone Medical, Inc. (2004) Summary page 1.
- K033702: Blackstone Peek Vertebral Body Replacement System, Blackstone Medical, Inc. (2004) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 1.
- K033303: Wafer System, Spine Wave, Inc. (2004) Summary page 1.

## Most influential descendants
- K090315: Staxx XD System (2009), 6 descendants of its own
- K101288: Staxx XD System (2010), 5 descendants of its own
- 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

## Indications for use
The StaXxTM 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 bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.

Source page: https://510kreport.com/device/K052670
Methodology: https://510kreport.com/methodology