510(k) · Cleared
ClearedNuVasive® Lumbar Interbody Implants
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 24, 2016 as substantially equivalent to K143163 (Stryker Corporation, 2015) and 6 other predicates after an 84-day review. Its family tree reaches back 17 generations to 1984. 390 later devices descend from it.
- Decided
- Mar 24, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K841189 (1984). 172 ancestors in all. 390 later devices descend from it, 5 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 304 of its ownK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 4 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Showing 5 of 390 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 390 · See all- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly381descendants
- K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017 · 2 generations on304descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on251descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on227descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −4 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −2 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| 0 (this device) | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +2 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K172123 | NuVasive® Modulus XLIF Interbody 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 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 27 | 0 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 13 | 0 |
| 2018 | 15 | 0 |
| 2019 | 17 | 0 |
| 2020 | 34 | 0 |
| 2021 | 37 | 0 |
| 2022 | 47 | 0 |
| 2023 | 53 | 0 |
| 2024 | 71 | 0 |
| 2025 | 55 | 0 |
| 2026 | 45 | 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? (7)
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 |
|---|---|---|---|
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 5…Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, and Aero™-AL Lumbar Cage System (K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K1317… | 2015 |
| * | K141665 | NuVasive CoRoent SystemSummary page 5…ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, and Aero™-AL Lumbar Cage System (K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone… | 2015 |
| * | K140319 | Coroent TI-C SystemSummary page 5…L and PL Cage, AVS® Anchor-L Spacer, and Aero™-AL Lumbar Cage System (K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brig… | 2014 |
| * | K131723 | Coroent Single Tab SystemSummary page 5…and Aero™-AL Lumbar Cage System (K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brigade Hyperlordotic System (K123045).… | 2013 |
| * | K140479 | Coroent XL-F SystemSummary page 5…(K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brigade Hyperlordotic System (K123045). D. Device Description The sub… | 2014 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 5…es, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brigade Hyperlordotic System (K123045). D. Device Description The subject NuVasive Lumbar Interbody Implants a… | 2010 |
| * | K123045 | Brigade Standalone SystemSummary page 5…ystem (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brigade Hyperlordotic System (K123045). D. Device Description The subject NuVasive Lumbar Interbody Implants are interbody implants manufactured from PEEK… | 2013 |
What descends from it? (390)
See all 3905 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 32 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 21 of the 172 ancestors have a recall of any class.
- Of its descendants, K161230 (Nu Vasive, Incorporated, 2016) has gone furthest, with 381 descendants of its own.
- 11 other devices also cite its predicate K143163.
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. 2016, 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?
NuVasive® Lumbar Non-Interfixated Interbody Implants: The NuVasive Lumbar Non-Interfixated Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are 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 system…
Read the full statement (328 words)
NuVasive® Lumbar Non-Interfixated Interbody Implants:
The NuVasive Lumbar Non-Interfixated Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are 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 system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-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.
NuVasive® Lumbar Interfixated Interbody Implants:
The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Interfixated Interbody Implants are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) 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.
CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153782: NuVasive® Lumbar Interbody Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153782
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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