510(k) · Cleared
ClearedNuVasive Cohere Thoracolumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 30, 2020 as substantially equivalent to K181860 (Nu Vasive, Incorporated, 2018) and 4 other predicates after a 101-day review. Its family tree reaches back 22 generations to 1984. 157 later devices descend from it.
- Decided
- Mar 30, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K841189 (1984). 222 ancestors in all. 157 later devices descend from it, 3 citing it directly.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017
- 1 generation backK181860 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018
- This deviceK193541 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
- Descendant · cites it directly · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- Descendant · cites it directly · 94 of its ownK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
- Descendant · 2 generations on · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 2 generations on · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- Descendant · 3 generations on · 55 of its ownK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017
- 1 generation backK181860 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018
- This deviceK193541 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 157 · See all- K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · cites it directly156descendants
- K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2021 · cites it directly94descendants
- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · 2 generations on75descendants
- K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · 2 generations on66descendants
- K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2018 | — |
| 0 (this device) | K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020 | — |
| +1 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| +1 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2021 | — |
| +2 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +2 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| +3 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 31 | 0 |
| 2009 | 17 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 23 | 0 |
| 2024 | 43 | 0 |
| 2025 | 35 | 0 |
| 2026 | 29 | 0 |
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 MAX? 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 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181860 | NuVasive Cohere Thoracolumbar Interbody SystemSummary page 4…s The subject NuVasive Cohere Thoracolumbar Interbody System is substantially equivalent to the primary predicate device, NuVasive Cohere Thoracolumbar Interbody System (K181860) and additional predicates Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (K173153), NuVasive CoRoent Thoracolumb… | 2018 |
| * | K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemSummary page 4…mary predicate device, NuVasive Cohere Thoracolumbar Interbody System (K181860) and additional predicates Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (K173153), NuVasive CoRoent Thoracolumbar System (K170962), NuVasive CoRoent System (K141665), and NuVasive CoRoent Ti-C System (K140319).… | 2017 |
| * | K170962 | NuVasive® CoRoent® Thoracolumbar SystemSummary page 4…bar Interbody System (K181860) and additional predicates Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (K173153), NuVasive CoRoent Thoracolumbar System (K170962), NuVasive CoRoent System (K141665), and NuVasive CoRoent Ti-C System (K140319). D. Device Description The NuVasive Cohere Thora… | 2017 |
| * | K141665 | NuVasive CoRoent SystemSummary page 4…additional predicates Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (K173153), NuVasive CoRoent Thoracolumbar System (K170962), NuVasive CoRoent System (K141665), and NuVasive CoRoent Ti-C System (K140319). D. Device Description The NuVasive Cohere Thoracolumbar Interbody System comprises… | 2015 |
| * | K140319 | Coroent TI-C SystemSummary page 4…e™ Thoracolumbar Interbody Fusion System (K173153), NuVasive CoRoent Thoracolumbar System (K170962), NuVasive CoRoent System (K141665), and NuVasive CoRoent Ti-C System (K140319). D. Device Description The NuVasive Cohere Thoracolumbar Interbody System comprises of sterile, single use implant grade polyet… | 2014 |
What descends from it? (157)
See all 1573 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 23 of the 222 ancestors have a recall of any class.
- Of its descendants, K201820 (Nu Vasive, Incorporated, 2020) has gone furthest, with 156 descendants of its own.
- 4 other devices also cite its predicate K181860.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The NuVasive Cohere Thoracolumbar 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…
Read the full statement (181 words)
The NuVasive Cohere Thoracolumbar 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 Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12, at the thoracolumbar junction (T12-L1), and 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 Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193541: NuVasive Cohere Thoracolumbar 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/K193541
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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