510(k) Report

510(k) · Cleared

Cleared

NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System

K210214510(k) TraditionalCleared May 24, 2021117-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 May 24, 2021 as substantially equivalent to K201820 (Nu Vasive, Incorporated, 2020) and 5 other predicates after a 117-day review. Its family tree reaches back 24 generations to 1984. 1 of the 395 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
May 24, 2021
Review
117 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 24 generations to K841189 (1984). 391 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 1 citing it directly. 1 of the 395 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2020: 2 other ancestors2017: 9 other ancestors2015: 17 other ancestors2011: 28 other ancestors2019: 1 other ancestor2018: 3 other ancestors2016: 9 other ancestors2014: 23 other ancestors2013: 25 other ancestors2012: 22 other ancestors2009: 33 other ancestors2008: 47 other ancestors, 1 with a Class I recall12007: 18 other ancestors2010: 21 other ancestors2006: 13 other ancestors2005: 20 other ancestors2003: 18 other ancestors2002: 9 other ancestors1999: 2 other ancestors2004: 28 other ancestors2001: 10 other ancestors2000: 2 other ancestors1996: 2 other ancestors1997: 1 other ancestor1993: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2023: 1 descendant cleared2024: 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) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×2: 2 generations cleared close together, K141217 (2014), K143163 (2015) ×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) ×3: 3 generations cleared close together, K170962 (2017), K171633 (2017), K172341 (2017) ×2: 2 generations cleared close together, K193593 (2020), K201820 (2020) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 31 other ancestors3 generations back: 72 other ancestors4 generations back: 94 other ancestors, 1 with a Class I recall15 generations back: 77 other ancestors6 generations back: 47 other ancestors7 generations back: 28 other ancestors8 generations back: 6 other ancestors9 generations back: 1 other ancestor10 generations back: 4 other ancestors11 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K201820 · NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K193593 · NuVasive 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K172341 · NuVasive® Modulus TLIF Interbody System · Nu Vasive, Incorporated · 2017K171633 · NuVasive TLX Interbody System · Nu Vasive, Incorporated · 2017K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · 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. · 1984−20−15−10−50
  1. Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 20 generations between
  3. 3 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  4. 2 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  5. 1 generation backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  6. This deviceK210214 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody…Nu Vasive, Incorporated · 2021
  7. Descendant · cites it directly · 2 of its ownK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
  8. Descendant · 2 generations on · 0 of its ownK253401 SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026
  9. Descendant · 2 generations on · 0 of its ownK234035 COSINE™ SpacerGlobus Medical, Inc. · 2024
Show all 24 generations
  1. Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 7 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 6 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 5 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. 4 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  22. 3 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  23. 2 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  24. 1 generation backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  25. This deviceK210214 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody…Nu Vasive, Incorporated · 2021

Class I recalls in this family

Most influential descendants

Showing 3 of 3 · See all
  • K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023 · cites it directly2descendants
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026 · 2 generations on0descendants
  • K234035COSINE™ SpacerGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−24K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−23K990148Stackable Cage SystemDepuy Motech Acromed1999—
−22K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−21K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−20K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−19K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−18K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−17K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−16K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−15K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−14K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−13K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−12K121683Acculif TL CageCoalign Innovations, Inc.2012—
−11K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−10K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−9K141217Acculif TL and PL CageStryker Corporation20143
−8K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
−4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
−3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017—
−2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020—
−1K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System…Nu Vasive, Incorporated2020—
0 (this device)K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated2021—
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.2023—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.2026—
+2K234035COSINE™ SpacerGlobus Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199310
199620
199710
199810
199920
200020
2001100
200290
2003180
2004280
2005200
2006130
2007180
2008471
2009330
2010210
2011280
2012220
2013250
2014230
2015170
201690
201790
201830
201910
202020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202410
202610
FIG. 1 — Lineage of K210214, 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
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What was it cleared against? (6)

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
*K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…
Summary page 4
…pandable Posterior Lumbar MOD-EX PL Interbody System is substantially equivalent to the primary predicate device NuVasive Modulus TLIF Interbody System cleared in 510(k) K201820. Additional predicates include: Globus Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expa…
Nu Vasive, Incorporated2020—
*K102293Caliber Spacer
Summary page 4
…equivalent to the primary predicate device NuVasive Modulus TLIF Interbody System cleared in 510(k) K201820. Additional predicates include: Globus Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody I…
Globus Medical, Inc.2011—
*K192115SABLE Expandable Spacer
Summary page 4
…NuVasive Modulus TLIF Interbody System cleared in 510(k) K201820. Additional predicates include: Globus Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody Implants (K141665), and NuVasive Modulus XL…
Globus Medical, Inc.2020—
*K163364MOJAVE Expandable Interbody System
Summary page 4
…510(k) K201820. Additional predicates include: Globus Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody Implants (K141665), and NuVasive Modulus XLIF Interbody System (K163230). Device Description…
K2m2017—
*K141665NuVasive CoRoent System
Summary page 4
…Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody Implants (K141665), and NuVasive Modulus XLIF Interbody System (K163230). Device Description The subject Modulus Expandable Posterior Lumbar MOD-…
Nuvasive, Inc.2015—
*K163230NuVasive Modulus XLIF Interbody System
Summary page 4
…ble Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody Implants (K141665), and NuVasive Modulus XLIF Interbody System (K163230). Device Description The subject Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is a thoracolumbar interbody sy…
Nu Vasive, Incorporated2017—

Also cleared against K201820: 4 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232

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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 37 years and passes through 12 companies; a new generation was cleared every 10 months on median.
  • 41 of the 391 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K221894 (Globus Medical, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K201820.

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. 2021, 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 Expandable Posterior Lumbar MOD-EX PL 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. The System is designed for use with supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine.…

Read the full statement (207 words)

The NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL 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. The System is designed for use with 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 Expandable Posterior Lumbar MOD-EX PL Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic degenerative disc disease (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 Expandable Posterior Lumbar MOD-EX PL Interbody System be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K210214: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210214

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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