510(k) · Cleared
ClearedNuVasive® CoRoent® Thoracolumbar 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 Jun 26, 2017 as substantially equivalent to K161230 (Nu Vasive, Incorporated, 2016) and 2 other predicates after an 87-day review. Its family tree reaches back 19 generations to 1984. 304 later devices descend from it.
- Decided
- Jun 26, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 200 ancestors in all. 304 later devices descend from it, 12 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 163 of its ownK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
- Descendant · cites it directly · 163 of its ownK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 160 of its ownK173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
Showing 5 of 304 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 304 · See all- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly251descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly227descendants
- K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019 · 2 generations on163descendants
- K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly163descendants
- K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017 · cites it directly160descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019 | — |
| +1 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated | 2017 | — |
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 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 29 | 0 |
| 2009 | 15 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 8 | 0 |
| 2020 | 21 | 0 |
| 2021 | 26 | 0 |
| 2022 | 37 | 0 |
| 2023 | 43 | 0 |
| 2024 | 62 | 0 |
| 2025 | 50 | 0 |
| 2026 | 43 | 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? (3)
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 |
|---|---|---|---|
| * | K161230 | NuVasive Lumbar Interbody ImplantsSummary page 4…cate Devices The subject NuVasive CoRoent Thoracolumbar System is substantially equivalent to the primary predicate device, NuVasive Lumbar Interbody Implants (K161230), and additional predicates NuVasive CoRoent Thoracolumbar System (K153419) and NuVasive CoRoent Titanium System (K1209… | 2016 |
| * | K153419 | NuVasive CoRoent Thoracolumbar SystemSummary page 4…ally equivalent to the primary predicate device, NuVasive Lumbar Interbody Implants (K161230), and additional predicates NuVasive CoRoent Thoracolumbar System (K153419) and NuVasive CoRoent Titanium System (K120918). D. Device Description The subject NuVasive CoRoent Thoracolumbar Sy… | 2016 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 4…, NuVasive Lumbar Interbody Implants (K161230), and additional predicates NuVasive CoRoent Thoracolumbar System (K153419) and NuVasive CoRoent Titanium System (K120918). D. Device Description The subject NuVasive CoRoent Thoracolumbar System consists of devices manufactured from tita… | 2012 |
What descends from it? (304)
See all 30412 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171633 | NuVasive TLX Interbody System | 2017 | 251 |
| K172123 | NuVasive® Modulus XLIF Interbody System | 2017 | 227 |
| K172341 | NuVasive® Modulus TLIF Interbody System | 2017 | 163 |
| K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | 2017 | 160 |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | 2018 | 159 |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | 2020 | 157 |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL… | 2020 | 156 |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | 2020 | 141 |
| K181453 | ATEC ALIF Spacer System | 2018 | 111 |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | 2018 | 97 |
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 33 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 21 of the 200 ancestors have a recall of any class.
- Of its descendants, K171633 (Nu Vasive, Incorporated, 2017) has gone furthest, with 251 descendants of its own.
- 15 other devices also cite its predicate K161230.
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. 2017, 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® CoRoent® Thoracolumbar 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 (199 words)
The NuVasive® CoRoent® Thoracolumbar 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 CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L.1), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended 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 CoRoent Thoracolumbar System (XL and L platforms) 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/K170962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170962: NuVasive® CoRoent® Thoracolumbar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170962
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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