# K123461: Staxx (R) IB System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 11, 2013 after 153 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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: 12 generations back to K841189 (1984). 23 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 1.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 1.
- K113527: Opticage Interbody Fusion Device, Interventional Spine, Inc. (2012) Summary page 1.

## Most influential descendants
- K133514: Xcage Interbody Fusion System (2014), 15 descendants of its own
- K160076: XCage™ Interbody Fusion System (2016), 14 descendants of its own
- K183184: FlareHawk Interbody Fusion System (2019), 12 descendants of its own
- K131071: Staxx Ibl System (2013), 8 descendants of its own
- K132719: Staxx Ibl System (2013), 7 descendants of its own

## Recalls of this device
- May 14, 2013 · Class II · Z-2187-2013: A component Superior endplate manufactured from a different polymer than specified

## Indications for use
The StaXx® LB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx IB 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/K123461
Methodology: https://510kreport.com/methodology