510(k) Report

510(k) · Cleared

Cleared

Irix-C Cervical Integrated Fusion System

K131951510(k) TraditionalCleared Aug 14, 201348-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

X-Spine Systems, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Aug 14, 2013 as substantially equivalent to K083389 (Globus Medical, Inc., 2009) and 2 other predicates after a 48-day review. Its family tree reaches back 12 generations to 1984. 12 later devices descend from it.

Decided
Aug 14, 2013
Review
48 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
3

Its longest line of descent runs back 12 generations to K841189 (1984). 48 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 3 other ancestors2008: 4 other ancestors2007: 1 other ancestor2002: 5 other ancestors2001: 9 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2016: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 2 descendants cleared2023: 2 descendants cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalledK120819 · Stalif C · Centinel Spine, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 1 other ancestor4 generations back: 8 other ancestors5 generations back: 5 other ancestors6 generations back: 5 other ancestors7 generations back: 6 other ancestors8 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 4 descendants K120819 · Stalif C · Centinel Spine, Inc. · 2012K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalledK091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  4. 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  5. 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
  6. This deviceK131951 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2013
  7. Descendant · cites it directly · 9 of its ownK151934 ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
  8. Descendant · 2 generations on · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
  9. Descendant · 3 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
  10. Descendant · 4 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
  11. Descendant · 5 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
Show all 12 generations
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  12. 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
  13. This deviceK131951 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2013

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 22019: 12023: 22024: 32025: 12026: 1
2015high 3 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 12 · See all
  • K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015 · cites it directly9descendants
  • K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · 2 generations on7descendants
  • K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on6descendants
  • K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 4 generations on5descendants
  • K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−11K990148Stackable Cage SystemDepuy Motech Acromed1999—
−10K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−9K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−8K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−7K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−6K043479MC+ Partial VBRLdr Spine USA2005—
−5K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−4K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
−2K102606Avs Anchor-C Cervical Cage SystemStryker Spine20111
−1K120819Stalif CCentinel Spine, Inc.2012—
0 (this device)K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.2013—
+1K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA2015—
+2K181621Stable-C Interbody SystemNexus Spine, LLC2018—
+3K231763Stable-C Interbody SystemNexus Spine, LLC2023—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC2023—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200190
200250
200340
200440
200520
200710
200840
200930
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201820
201910
202320
202430
202510
202610
FIG. 1 — Lineage of K131951, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OVE? 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K083389Coalition Spacer
Summary page 2
…ical Approach *Anatomical Region *Implant Materials *Product Dimensions *Mechanical Performance PREDICATE DEVICES *Globus Medical, Inc. - COALITION Spacer (K(083389) *Centinel Spine, Inc. - STALIF-C (K120819) *X-spine Systems, Inc..- Calix PC Spinal Implant System (K1 12036) PERFORMANCE D…
Globus Medical, Inc.2009—
*K120819Stalif C
Summary page 2
…t Materials *Product Dimensions *Mechanical Performance PREDICATE DEVICES *Globus Medical, Inc. - COALITION Spacer (K(083389) *Centinel Spine, Inc. - STALIF-C (K120819) *X-spine Systems, Inc..- Calix PC Spinal Implant System (K1 12036) PERFORMANCE DATA The implant components were tested using…
Centinel Spine, Inc.2012—
*K112036Calix PC Spinal Implant System
Summary page 2
…TE DEVICES *Globus Medical, Inc. - COALITION Spacer (K(083389) *Centinel Spine, Inc. - STALIF-C (K120819) *X-spine Systems, Inc..- Calix PC Spinal Implant System (K1 12036) PERFORMANCE DATA The implant components were tested using the following standards: ASTM F2077 - Test Methods for Interverte…
X-Spine Systems, Inc.2011—

Also cleared against K083389: 21 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159
K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
  • 4 of the 48 ancestors have a recall of any class.
  • Of its descendants, K151934 (Ldr Spine USA, 2015) has gone furthest, with 9 descendants of its own.
  • 21 other devices also cite its predicate K083389.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device

intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for

treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the

disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior

approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of non-

operative treatment prior to treatment with a cervical intervertebral fusion device.

Indications for use as stated in the FDA summary.

Also cleared against K083389

21 other devices cite the same predicate.

  • K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
  • K191477AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS…Globus Medical, Inc. · 2016
  • K151939COALITION SpacersGlobus Medical, Inc. · 2016
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K131951 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131951: Irix-C Cervical 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/K131951

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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