510(k) Report

510(k) · Cleared

Cleared

NuVasive CoRoent System

K141665510(k) TraditionalCleared Mar 13, 2015263-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 Mar 13, 2015 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 11 other predicates after a 263-day review. Its family tree reaches back 14 generations to 1984. 1 of the 721 devices in its family, counting itself, has a Class I recall. 588 later devices descend from it.

Decided
Mar 13, 2015
Review
263 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
12

Its longest line of descent runs back 14 generations to K841189 (1984). 132 ancestors in all. 588 later devices descend from it, 18 citing it directly. 1 of the 721 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2014: 3 other ancestors2013: 6 other ancestors2012: 3 other ancestors2011: 6 other ancestors2009: 10 other ancestors2008: 20 other ancestors2007: 11 other ancestors2010: 6 other ancestors2006: 3 other ancestors2005: 7 other ancestors2003: 10 other ancestors2002: 8 other ancestors1999: 2 other ancestors2004: 10 other ancestors2001: 10 other ancestors1996: 2 other ancestors2000: 1 other ancestor2016: 17 descendants cleared2018: 31 descendants cleared2015: 5 descendants cleared2017: 27 descendants cleared2020: 64 descendants cleared2021: 51 descendants cleared, 1 with a Class I recall12019: 43 descendants cleared2025: 72 descendants cleared2024: 83 descendants cleared2023: 76 descendants cleared2022: 61 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 · 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. · 2007×3: 3 generations cleared close together, K080083 (2008), K073109 (2008), K081849 (2008) K100043 · Coroent XLR Standalone System · Nuvasive, Inc. · 2010K123045 · Brigade Standalone System · Nuvasive, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 35 other ancestors3 generations back: 33 other ancestors4 generations back: 24 other ancestors5 generations back: 10 other ancestors6 generations back: 5 other ancestors 1 generation forward: 18 descendants2 generations forward: 71 descendants3 generations forward: 124 descendants, 1 with a Class I recall14 generations forward: 170 descendants5 generations forward: 114 descendants6 generations forward: 58 descendants7 generations forward: 24 descendants8 generations forward: 7 descendants9 generations forward: 2 descendants K123045 · Brigade Standalone System · Nuvasive, Inc. · 2013K100043 · Coroent XLR Standalone System · Nuvasive, Inc. · 2010K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · 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. · 1984−10−50+5
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  4. 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
  5. 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
  6. This deviceK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
  7. Descendant · cites it directly · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
  8. Descendant · cites it directly · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
  9. Descendant · 2 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
  10. Descendant · 3 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
  11. Descendant · cites it directly · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
  14. 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
  15. This deviceK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015

Showing 5 of 588 descendants. See all descendants

Descendants cleared per year

2015: 52016: 172017: 272018: 312019: 432020: 642021: 512022: 612023: 762024: 832025: 722026: 58
2015high 83 (2024) · low 5 (2015)2026

Class I recalls in this family

  • K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 588 · See all
  • K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · cites it directly479descendants
  • K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · cites it directly402descendants
  • K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 2 generations on400descendants
  • K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 3 generations on396descendants
  • K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly390descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−6K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−5K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−4K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010—
−1K123045Brigade Standalone SystemNuvasive, Inc.2013—
0 (this device)K141665NuVasive CoRoent SystemNuvasive, Inc.2015—
+1K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015—
+1K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015—
+2K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
2003100
2004100
200570
200630
2007110
2008200
2009100
201060
201160
201230
201360
201430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201550
2016170
2017270
2018310
2019430
2020640
2021511
2022610
2023760
2024830
2025720
2026580
FIG. 1 — Lineage of K141665, 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? (12)

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 System is substantially equivalent to the primary predicate device, NuVasive CoRoent System (K071795), and the following additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K…
Nuvasive, Inc.2007—
*K113348Cougar System
Summary page 4
…lly equivalent to the primary predicate device, NuVasive CoRoent System (K071795), and the following additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar…
Johnson & Johnson2011—
*K120918Nuvasive Coroent Titanium System
Summary page 4
…ce, NuVasive CoRoent System (K071795), and the following additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Int…
Nuvasive, Inc.2012—
*K123045Brigade Standalone System
Summary page 4
…llowing additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL…
Nuvasive, Inc.2013—
*K130820Expandable Lumbar Interbody System
Summary page 4
…ant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer Sy…
Nu Vasive, Incorporated2013—
*K131082Interform Interbody Cage System
Summary page 4
…nium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C…
Next Orthosurgical2013—
*K132601Coroent Sterile Implants System
Summary page 4
…dotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. I…
Nu Vasive, Incorporated2013—
*K080699Novel Spinal Spacer System
Summary page 4
…bar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Repla…
Alphatec Spine, Inc.20081
*K140319Coroent TI-C System
Cleared while this submission was under review
Summary page 4
…m Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine…
Nuvasive, Inc.2014—
*K133455Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic
Summary page 4
…cer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine AVS PL PEEK Spacers (K090816), and Globus Medical Inc. Caliber Spacers (K123231). D. Device Description…
Pioneer Surgical Technology, Inc.20141
*K090816Stryker Spine Avs PL Peek Spacers
Summary page 4
…ystem (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine AVS PL PEEK Spacers (K090816), and Globus Medical Inc. Caliber Spacers (K123231). D. Device Description The NuVasive® CoRoent System is manufactured f…
Stryker Corp.2009—
*K123231Caliber Spacers
Summary page 4
…Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine AVS PL PEEK Spacers (K090816), and Globus Medical Inc. Caliber Spacers (K123231). D. Device Description The NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-k…
Globus Medical, Inc.2013—

Also cleared against K071795: 41 other devices →

What descends from it? (588)

See all 588

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

NumberDeviceApplicantDecidedDescendants
K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479
K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402
K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390
K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276
K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253
K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252
K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251
K151322Amendia Interbody Fusion DevicesAmendia, Inc.2015226
K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169
K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163

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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 31 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
  • 19 of the 132 ancestors have a recall of any class.
  • Of its descendants, K151472 (Nu Vasive, Incorporated, 2015) has gone furthest, with 479 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. 2015, 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 Lumbar 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 and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are to be used in patients who have…

Read the full statement (144 words)

The NuVasive CoRoent Lumbar 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 and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are to be used in patients who have had at least six months of non-operative treatment.

The CoRoent Lumbar System (L and XL platforms) 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.

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

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
  • K141896Coroent SystemNu Vasive, Incorporated · 2014

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/K141665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141665: NuVasive CoRoent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141665

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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