# K133947: Irix-a Lumbar Integrated Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Jul 29, 2014 after 218 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 11 generations back to K841189 (1984). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 2.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 2.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 2.

## Most influential descendants
- K171567: IRIX-A Lumbar Integrated Fusion System (2017), 0 descendants of its own
- K161993: Leva® Anterior Interbody System (2016), 0 descendants of its own

## Indications for use
The lrix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DOD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-Sl inclusive). ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The lrix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.

Source page: https://510kreport.com/device/K133947
Methodology: https://510kreport.com/methodology