# K171567: IRIX-A Lumbar Integrated Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Aug 28, 2017 after 90 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 15 generations back to K003155 (2001). 138 ancestors in all.
No later device cites it as a predicate yet.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133947: Irix-a Lumbar Integrated Fusion System, X-Spine Systems, Inc. (2014) Summary page 5.
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer, Globus Medical, Inc. (2017) Summary page 5.

## Recalls of this device
- Jan 3, 2025 · Class II · Z-1177-2025: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

## Indications for use
The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD 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 IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous and/or corticancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system. Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Source page: https://510kreport.com/device/K171567
Methodology: https://510kreport.com/methodology