510(k) · Cleared
Recalled · Class II · 2025IRIX-A Lumbar Integrated Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 28, 2017 as substantially equivalent to K133947 (X-Spine Systems, Inc., 2014) and 1 other predicate after a 90-day review. Its family tree reaches back 15 generations to 2001. It has been recalled once.
- Decided
- Aug 28, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 15 generations to K003155 (2001). 138 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 2 generations backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- 1 generation backK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- This deviceK171567 IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 2017
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 2 generations backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- 1 generation backK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- This deviceK171567 IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| −2 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| −1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| 0 (this device) | K171567 | IRIX-A Lumbar Integrated Fusion System | X-Spine Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 12 | 0 |
| 2004 | 20 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133947 | Irix-a Lumbar Integrated Fusion SystemSummary page 5…llous and/or corticancellousbonegraftmaterial. VI. PREDICATEDEVICES x Primary:XͲspine,Inc.:IRIXͲA™LumbarIntegratedFusionSystem–K133947 x Additional:GlobusMedical,Inc.:INDEPENDENCE®SpacersͲͲK152022 VII. REFERENCEDEVICES x NuVasive,… | 2014 |
| * | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Summary page 5…DEVICES x Primary:XͲspine,Inc.:IRIXͲA™LumbarIntegratedFusionSystem–K133947 x Additional:GlobusMedical,Inc.:INDEPENDENCE®SpacersͲͲK152022 VII. REFERENCEDEVICES x NuVasive,BASEInterfixatedTitaniumSystem(K170592) x Synthes,TͲPALSpacerSyste… | 2017 |
| † | K170592 | NuVasive BASE Interfixated Titanium System | 2017 |
| † | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | 2016 |
| † | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2025 | Class II | Z-1177-2025 | Labeling Change Control | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 14 of the 138 ancestors have a recall of any class.
- 1 other device also cites its predicate K133947.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
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…
Read the full statement (158 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171567: IRIX-A Lumbar Integrated Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171567
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026