510(k) Report

510(k) · Cleared

Cleared

Coroent TI-C System

K140319510(k) TraditionalCleared Oct 9, 2014241-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

Nuvasive, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Oct 9, 2014 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 4 other predicates after a 241-day review. Its family tree reaches back 12 generations to 1984. 1 of the 631 devices in its family, counting itself, has a Class I recall. 590 later devices descend from it.

Decided
Oct 9, 2014
Review
241 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K841189 (1984). 40 ancestors in all. 590 later devices descend from it, 10 citing it directly. 1 of the 631 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 3 other ancestors2012: 1 other ancestor2007: 4 other ancestors2011: 1 other ancestor2008: 5 other ancestors2010: 1 other ancestor2009: 3 other ancestors2003: 2 other ancestors2001: 3 other ancestors1999: 1 other ancestor1996: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor2015: 7 descendants cleared2017: 27 descendants cleared2016: 17 descendants cleared2020: 64 descendants cleared2018: 31 descendants cleared2021: 51 descendants cleared, 1 with a Class I recall12022: 61 descendants cleared2023: 76 descendants cleared2019: 43 descendants cleared2025: 72 descendants cleared2024: 83 descendants cleared2026: 58 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K081917 · Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems · Depuy Spine, Inc. · 2009×2: 2 generations cleared close together, K101923 (2010), K110454 (2011) K113348 · Cougar System · Johnson & Johnson · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 12 other ancestors4 generations back: 6 other ancestors 1 generation forward: 10 descendants2 generations forward: 35 descendants3 generations forward: 112 descendants4 generations forward: 159 descendants, 1 with a Class I recall15 generations forward: 127 descendants6 generations forward: 83 descendants7 generations forward: 42 descendants8 generations forward: 16 descendants9 generations forward: 5 descendants10 generations forward: 1 descendant K113348 · Cougar System · Johnson & Johnson · 2011K110454 · Cougar LS Lateral Cage System · Johnson & Johnson · 2011K101923 · Concorde Curve System · Depuy Spine · 2010K081917 · Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems · Depuy Spine, Inc. · 2009K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · 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+10
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
  4. 2 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
  5. 1 generation backK113348 Cougar SystemJohnson & Johnson · 2011
  6. This deviceK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
  7. Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
  8. Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
  9. Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
  10. Descendant · 3 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
  11. Descendant · 4 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
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 backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 4 generations backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  10. 3 generations backK101923 Concorde Curve SystemDepuy Spine · 2010
  11. 2 generations backK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
  12. 1 generation backK113348 Cougar SystemJohnson & Johnson · 2011
  13. This deviceK140319 Coroent TI-C SystemNuvasive, Inc. · 2014

Showing 5 of 590 descendants. See all descendants

Descendants cleared per year

2015: 72016: 172017: 272018: 312019: 432020: 642021: 512022: 612023: 762024: 832025: 722026: 58
2015high 83 (2024) · low 7 (2015)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 590 · See all
  • K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
  • K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
  • K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
  • K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 3 generations on400descendants
  • K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 4 generations on396descendants
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—
−9K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−8K030833Depuy Acromed VBR SystemDepuyacromed2003—
−7K031635Depuy Acromed VBR SystemDepuyacromed2003—
−6K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−5K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−4K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.2009—
−3K101923Concorde Curve SystemDepuy Spine2010—
−2K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011—
−1K113348Cougar SystemJohnson & Johnson2011—
0 (this device)K140319Coroent TI-C SystemNuvasive, Inc.2014—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015—
+3K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199910
200010
200130
200210
200320
200740
200850
200930
201010
201110
201210
201330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201570
2016170
2017270
2018310
2019430
2020640
2021511
2022610
2023760
2024830
2025720
2026580
FIG. 1 — Lineage of K140319, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K071795Nuvasive Coroent System
Summary page 4
…MAX C. Predicate Devices The subject CoRoent Ti-C System is substantially equivalent to the primary predicate device: NuVasive CoRoent System (K071795). Additional predicate devices include: NuVasive CoRoent Sterile Implants (K132601), Spinal Elements Lucent (K110632 an…
Nuvasive, Inc.2007—
*K132601Coroent Sterile Implants System
Summary page 4
…ntially equivalent to the primary predicate device: NuVasive CoRoent System (K071795). Additional predicate devices include: NuVasive CoRoent Sterile Implants (K132601), Spinal Elements Lucent (K110632 and K122967), and DePuy Spine Cougar Implant System (K113348). D. Device Description…
Nu Vasive, Incorporated2013—
*K110632Lucent or Lucent Magnum
Summary page 4
…predicate device: NuVasive CoRoent System (K071795). Additional predicate devices include: NuVasive CoRoent Sterile Implants (K132601), Spinal Elements Lucent (K110632 and K122967), and DePuy Spine Cougar Implant System (K113348). D. Device Description The NuVasive® CoRoent Ti-C Syst…
Spinal Elements, Inc.20121
*K122967Lucent
Summary page 4
…vice: NuVasive CoRoent System (K071795). Additional predicate devices include: NuVasive CoRoent Sterile Implants (K132601), Spinal Elements Lucent (K110632 and K122967), and DePuy Spine Cougar Implant System (K113348). D. Device Description The NuVasive® CoRoent Ti-C System is manufacture…
Spinal Elements, Inc.2013—
*K113348Cougar System
Summary page 4
…al predicate devices include: NuVasive CoRoent Sterile Implants (K132601), Spinal Elements Lucent (K110632 and K122967), and DePuy Spine Cougar Implant System (K113348). D. Device Description The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyether- ether-ketone…
Johnson & Johnson2011—

Also cleared against K071795: 41 other devices →

What descends from it? (590)

See all 590

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

NumberDeviceApplicantDecidedDescendants
K141665NuVasive CoRoent SystemNuvasive, Inc.2015588
K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390
K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276
K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253
K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187
K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157
K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139
K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135
K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067
K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 40 ancestors have a recall of any class.
  • Of its descendants, K141665 (Nuvasive, Inc., 2015) has gone furthest, with 588 descendants of its own.
  • 41 other devices also cite its predicate K071795.

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. 2014, 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 CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic…

Read the full statement (133 words)

The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients.

The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K071795

41 other devices cite the same predicate.

  • K171151ACRON™ TLIF SystemSpinemed Ges.M.B.H · 2018
  • K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  • K160916CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
  • K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated · 2015
  • K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015
  • K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015

More from Nuvasive, Inc.

117 FDA decisions under this applicant name. See the company

  • P200022/S016Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S017Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S012Simplify DiscNuvasive, Inc. · 2025
  • P200022/S015Simplify Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S014Simplify Cervical Artificial DiscNuvasive, Inc. · 2024

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/K140319 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140319: Coroent TI-C System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140319

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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