510(k) · Cleared
ClearedMLX - Medial Lateral Expandable Lumbar 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 Jul 25, 2014 as substantially equivalent to K130820 (Nu Vasive, Incorporated, 2013) and 1 other predicate after a 120-day review. Its family tree reaches back 10 generations to 1984. 269 later devices descend from it.
- Decided
- Jul 25, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K841189 (1984). 30 ancestors in all. 269 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- 2 generations backK112359 Prow FusionNlt Spine, Ltd. · 2011
- 1 generation backK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- This deviceK140770 MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 253 of its ownK143595 NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 252 of its ownK153627 NuVasive® TLX Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 235 of its ownK151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2015
- Descendant · cites it directly · 234 of its ownK153105 MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 3 generations backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- 2 generations backK112359 Prow FusionNlt Spine, Ltd. · 2011
- 1 generation backK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- This deviceK140770 MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2014
Showing 5 of 269 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 269 · See all- K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated · 2015 · cites it directly253descendants
- K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated · 2016 · cites it directly252descendants
- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly251descendants
- K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated · 2015 · cites it directly235descendants
- K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016 · cites it directly234descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −3 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| −2 | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| −1 | K130820 | Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2013 | — |
| 0 (this device) | K140770 | MLX - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K143595 | NuVasive (R) CCX-L Interbody System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K153627 | NuVasive® TLX Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP… | Nu Vasive, Incorporated | 2015 | — |
| +1 | K153105 | MLX™ - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 17 | 0 |
| 2021 | 22 | 0 |
| 2022 | 30 | 0 |
| 2023 | 37 | 0 |
| 2024 | 54 | 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? (2)
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 |
|---|---|---|---|
| * | K130820 | Expandable Lumbar Interbody SystemSummary page 1…Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the following predicate devices: NuVasive® Expandable Lumbar Interbody System (K 130820) and Nu Vasive® CoRoent® Titanium System (K 120918). D. Device Description The NuVasive MLX- Medial Lateral Expandable Lu… | 2013 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 1…s substantially equivalent to the following predicate devices: NuVasive® Expandable Lumbar Interbody System (K 130820) and Nu Vasive® CoRoent® Titanium System (K 120918). D. Device Description The NuVasive MLX- Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-… | 2012 |
What descends from it? (269)
See all 2696 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143595 | NuVasive (R) CCX-L Interbody System | 2015 | 253 |
| K153627 | NuVasive® TLX Interbody System | 2016 | 252 |
| K171633 | NuVasive TLX Interbody System | 2017 | 251 |
| K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable… | 2015 | 235 |
| K153105 | MLX™ - Medial Lateral Expandable Lumbar Interbody System | 2016 | 234 |
| K173892 | NuVasive® XLX Interbody System | 2018 | 115 |
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 30 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K143595 (Nu Vasive, Incorporated, 2015) has gone furthest, with 253 descendants of its own.
- 3 other devices also cite its predicate K130820.
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. 2014, 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 MLX h - Medial Lateral Expandable Lumbar 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 NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI1, for the treatment of degenerative disc disease…
Read the full statement (164 words)
The NuVasive MLX h - Medial Lateral Expandable Lumbar 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 NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI1, for the treatment of degenerative disc disease (IDDD) with up to Grade I spondylolisthesis. DDID 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 NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System. The NuVasive MLX - Medial Lateral Expandable Lumbar 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/K140770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140770: MLX - Medial Lateral Expandable Lumbar 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/K140770
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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