# K133207: Staxx (R) System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Dec 6, 2013 after 49 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: 15 generations back to K841189 (1984). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121889: Staxx XD System, Spine Wave, Inc. (2012) Summary page 1.
- K102315: Staxx XDL System, Spine Wave, Inc. (2011) Summary page 1.
- K123461: Staxx (R) IB System, Spine Wave, Inc. (2013) Summary page 1.
- K132719: Staxx Ibl System, Spine Wave, Inc. (2013) Summary page 1.

## Most influential descendants
- K142996: StaXx (R) XD System (2015), 0 descendants of its own

## Indications for use
T1e StaXx®&Systems have the following indications: The Stax XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS5) 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; The StaXx® XDL System isa 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 used with autograft or allograft and supplemental spinal fixation. The StaXx@8 lB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx®I lB System is to be used wvith autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. The StaXx® IAL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from L2-LS. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K133207
Methodology: https://510kreport.com/methodology