# K131071: Staxx Ibl System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Aug 20, 2013 after 125 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 24 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123461: Staxx (R) IB System, Spine Wave, Inc. (2013) Summary page 1.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K132719: Staxx Ibl System (2013), 7 descendants of its own
- K140007: Abacus TM Spacer System (2014), 4 descendants of its own
- K152620: Spine Wave Gen II Expandable Interbody System (2016), 2 descendants of its own
- K162760: Spine Wave Anterior Cervical Spine System (2017), 1 descendant of its own
- K133207: Staxx (R) System (2013), 1 descendant of its own

## Indications for use
The StaXx® IBL 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-L5. 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® 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/K131071
Methodology: https://510kreport.com/methodology