# K121889: Staxx XD System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Aug 29, 2012 after 62 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 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K101482: EM-9000, Elite Medical, Inc. (2011). Our reading of the summary gave K101482, FDA’s number for EM-9000 (Elite Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “StaXx® XD System”. Kept off the family tree.

## Most influential descendants
- 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 Stax 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® XD System is the CapSure® PS Spine System.

Source page: https://510kreport.com/device/K121889
Methodology: https://510kreport.com/methodology