510(k) · Cleared
ClearedNuVasive® TLX 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 17, 2016 as substantially equivalent to K143595 (Nu Vasive, Incorporated, 2015) and 4 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1984. 252 later devices descend from it.
- Decided
- Mar 17, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K841189 (1984). 135 ancestors in all. 252 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK143595 NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated · 2015
- This deviceK153627 NuVasive® TLX Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 163 of its ownK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 157 of its ownK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- Descendant · 3 generations on · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- Descendant · 2 generations on · 115 of its ownK173892 NuVasive® XLX Interbody SystemNu Vasive, Incorporated · 2018
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK143595 NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated · 2015
- This deviceK153627 NuVasive® TLX Interbody SystemNu Vasive, Incorporated · 2016
Showing 5 of 252 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 252 · See all- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly251descendants
- K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on163descendants
- K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020 · 3 generations on157descendants
- K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · 3 generations on156descendants
- K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated · 2018 · 2 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −1 | K143595 | NuVasive (R) CCX-L Interbody System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K153627 | NuVasive® TLX Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| +3 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| +2 | K173892 | NuVasive® XLX Interbody System | Nu Vasive, Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 20 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 14 | 0 |
| 2021 | 20 | 0 |
| 2022 | 28 | 0 |
| 2023 | 36 | 0 |
| 2024 | 53 | 0 |
| 2025 | 45 | 0 |
| 2026 | 42 | 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 |
|---|---|---|---|
| * | K143595 | NuVasive (R) CCX-L Interbody SystemSummary page 4…MAX C. Predicate Devices The subject TLX Interbody System is substantially equivalent to multiple predicate devices. NuVasive® CCX-L Interbody System (K143595) serves as the primary predicate device, while Globus Medical Caliber® Spacer (K123231), NuVasive® CoRoent® Titanium System… | 2015 |
| * | K123231 | Caliber SpacersSummary page 4…ivalent to multiple predicate devices. NuVasive® CCX-L Interbody System (K143595) serves as the primary predicate device, while Globus Medical Caliber® Spacer (K123231), NuVasive® CoRoent® Titanium System (K120918), NuVasive® CoRoent® System (K141665) and NuVasive® MLX – Medial Lateral… | 2013 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 4…e® CCX-L Interbody System (K143595) serves as the primary predicate device, while Globus Medical Caliber® Spacer (K123231), NuVasive® CoRoent® Titanium System (K120918), NuVasive® CoRoent® System (K141665) and NuVasive® MLX – Medial Lateral Expandable Lumbar Interbody System (K140770) are ad… | 2012 |
| * | K141665 | NuVasive CoRoent SystemSummary page 4…erves as the primary predicate device, while Globus Medical Caliber® Spacer (K123231), NuVasive® CoRoent® Titanium System (K120918), NuVasive® CoRoent® System (K141665) and NuVasive® MLX – Medial Lateral Expandable Lumbar Interbody System (K140770) are additional predicate devices. D. Dev… | 2015 |
| * | K140770 | MLX - Medial Lateral Expandable Lumbar Interbody SystemSummary page 4…3231), NuVasive® CoRoent® Titanium System (K120918), NuVasive® CoRoent® System (K141665) and NuVasive® MLX – Medial Lateral Expandable Lumbar Interbody System (K140770) are additional predicate devices. D. Device Description The TLX Interbody intervertebral fusion device is designed to ad… | 2014 |
What descends from it? (252)
See all 2523 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 1.0 years on median.
- 19 of the 135 ancestors have a recall of any class.
- Of its descendants, K171633 (Nu Vasive, Incorporated, 2017) has gone furthest, with 251 descendants of its own.
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?
The NuVasive® TLX Interbody 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 TLX Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of…
Read the full statement (140 words)
The NuVasive® TLX Interbody 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 TLX Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the TLX Interbody System. The TLX Interbody 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.
https://510kreport.com/device/K153627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153627: NuVasive® TLX Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153627
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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