510(k) Report

510(k) · Cleared

Cleared

NuVasive Modulus XLIF Interbody System

K163230510(k) TraditionalCleared Mar 16, 2017119-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

Nu Vasive, Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Mar 16, 2017 as substantially equivalent to K161230 (Nu Vasive, Incorporated, 2016) and 4 other predicates after a 119-day review. Its family tree reaches back 19 generations to 1984. 1 of the 508 devices in its family, counting itself, has a Class I recall. 276 later devices descend from it.

Decided
Mar 16, 2017
Review
119 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
5

Its longest line of descent runs back 19 generations to K841189 (1984). 231 ancestors in all. 276 later devices descend from it, 11 citing it directly. 1 of the 508 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 4 other ancestors2015: 4 other ancestors2014: 9 other ancestors2013: 11 other ancestors2012: 10 other ancestors2011: 18 other ancestors2009: 18 other ancestors2008: 34 other ancestors, 1 with a Class I recall12007: 14 other ancestors2010: 13 other ancestors2006: 7 other ancestors2005: 12 other ancestors2003: 14 other ancestors2002: 9 other ancestors1999: 2 other ancestors2004: 19 other ancestors2001: 10 other ancestors1996: 2 other ancestors2000: 2 other ancestors2022: 32 descendants cleared2021: 24 descendants cleared2020: 21 descendants cleared2017: 3 descendants cleared2019: 11 descendants cleared2023: 41 descendants cleared2018: 2 descendants cleared2025: 46 descendants cleared2024: 56 descendants cleared2026: 40 descendants 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) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalled×2: 2 generations cleared close together, K143163 (2015), K143616 (2015) K152304 · Tritanium PL Cage · Stryker · 2015 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 26 other ancestors3 generations back: 61 other ancestors, 1 with a Class I recall14 generations back: 52 other ancestors5 generations back: 36 other ancestors6 generations back: 25 other ancestors7 generations back: 8 other ancestors 1 generation forward: 11 descendants2 generations forward: 27 descendants3 generations forward: 57 descendants4 generations forward: 63 descendants5 generations forward: 54 descendants6 generations forward: 36 descendants7 generations forward: 18 descendants8 generations forward: 7 descendants9 generations forward: 3 descendants K152304 · Tritanium PL Cage · Stryker · 2015 · recalledK143616 · AccuLIF TL and PL Cage · Stryker Corporation · 2015 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 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. · 1984−15−10−50+5
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 15 generations between
  3. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  4. 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  5. 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
  6. This deviceK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  7. Descendant · cites it directly · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  8. Descendant · cites it directly · 163 of its ownK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
  9. Descendant · cites it directly · 163 of its ownK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  10. Descendant · cites it directly · 157 of its ownK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  11. Descendant · 2 generations on · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
Show all 19 generations
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  19. 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
  20. This deviceK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 276 descendants. See all descendants

Descendants cleared per year

2017: 32018: 22019: 112020: 212021: 242022: 322023: 412024: 562025: 462026: 40
2017high 56 (2024) · low 2 (2018)2026

Class I recalls in this family

  • K073202 Ardis Spacer3 generations back · 2008

Most influential descendants

Showing 5 of 276 · See all
  • K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly227descendants
  • K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019 · cites it directly163descendants
  • K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly163descendants
  • K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020 · cites it directly157descendants
  • K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · 2 generations on156descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−18K990148Stackable Cage SystemDepuy Motech Acromed1999—
−17K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−16K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−15K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−14K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−13K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−12K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−11K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−10K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−9K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−7K121683Acculif TL CageCoalign Innovations, Inc.2012—
−6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−5K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−4K141217Acculif TL and PL CageStryker Corporation20143
−3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−2K143616AccuLIF TL and PL CageStryker Corporation20154
−1K152304Tritanium PL CageStryker20151
0 (this device)K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+1K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+1K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019—
+1K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017—
+1K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System…Nu Vasive, Incorporated2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
2001100
200290
2003140
2004190
2005120
200670
2007140
2008341
2009180
2010130
2011180
2012100
2013110
201490
201540
201640

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201730
201820
2019110
2020210
2021240
2022320
2023410
2024560
2025460
2026400
FIG. 1 — Lineage of K163230, 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.

1 device in this family has a Class I recall. 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (5)

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
*K161230NuVasive Lumbar Interbody Implants
Summary page 4
…The subject NuVasive Modulus XLIF Interbody System is substantially equivalent to the primary predicate device CoRoent® Lumbar Interbody Implants cleared in 510(k) K161230. Additional predicates include K2M CASCADIATM Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), C…
Nu Vasive, Incorporated2016—
*K150481Cascadia Interbody System
Summary page 4
…nt to the primary predicate device CoRoent® Lumbar Interbody Implants cleared in 510(k) K161230. Additional predicates include K2M CASCADIATM Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), CoRoent System (K141665), CoRoent Ti-C System (K140319) and CoRoent Ti-C…
K2m, Inc.20153
*K152304Tritanium PL Cage
Summary page 4
…Lumbar Interbody Implants cleared in 510(k) K161230. Additional predicates include K2M CASCADIATM Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), CoRoent System (K141665), CoRoent Ti-C System (K140319) and CoRoent Ti-C System (K140319). D. Device Description T…
Stryker20151
*K141665NuVasive CoRoent System
Summary page 4
…cleared in 510(k) K161230. Additional predicates include K2M CASCADIATM Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), CoRoent System (K141665), CoRoent Ti-C System (K140319) and CoRoent Ti-C System (K140319). D. Device Description The subject NuVasive Modulu…
Nuvasive, Inc.2015—
*K140319Coroent TI-C System
Summary page 4
…tional predicates include K2M CASCADIATM Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), CoRoent System (K141665), CoRoent Ti-C System (K140319) and CoRoent Ti-C System (K140319). D. Device Description The subject NuVasive Modulus XLIF Interbody System are interbod…
Nuvasive, Inc.2014—

Also cleared against K161230: 15 other devices →

What descends from it? (276)

See all 276

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

NumberDeviceApplicantDecidedDescendants
K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227
K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163
K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163
K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157
K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125
K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067
K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017
K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311
K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214
K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 33 years and passes through 13 companies; a new generation was cleared every 10 months on median.
  • 29 of the 231 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K172123 (Nu Vasive, Incorporated, 2017) has gone furthest, with 227 descendants of its own.
  • 15 other devices also cite its predicate K161230.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six…

Read the full statement (185 words)

The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K161230

15 other devices cite the same predicate.

  • K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated · 2022
  • K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated · 2021
  • K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System…Nu Vasive, Incorporated · 2021
  • K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System…Nu Vasive, Incorporated · 2020
  • K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  • K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K163230 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163230: NuVasive Modulus XLIF Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163230

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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