# K102315: Staxx XDL System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Aug 19, 2011 after 368 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). 57 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 61 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). Cleared while this submission was under review Summary page 1.
- K052210: Nuvasive Coroent Extensure System, Nuvasive, Inc. (2005) Summary page 1.
- K070218: Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR), Vertiflex (Tm), Incorporated (2007) Summary page 1.
- K052746: Concorde VBR Spinal System, Depuy Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.

Source page: https://510kreport.com/device/K102315
Methodology: https://510kreport.com/methodology