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 11, 2016 as substantially equivalent to K140770 (Nu Vasive, Incorporated, 2014) and 3 other predicates after a 258-day review. Its family tree reaches back 18 generations to 1984. 234 later devices descend from it.
- Decided
- Jul 11, 2016
- Review
- 258 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K841189 (1984). 113 ancestors in all. 234 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- 2 generations backK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
- 1 generation backK151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2015
- This deviceK153105 MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016
- 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 · 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 · cites it directly · 141 of its ownK200953 NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 6 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 5 generations backK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- 4 generations backK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- 3 generations backK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- 2 generations backK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
- 1 generation backK151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2015
- This deviceK153105 MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016
Showing 5 of 234 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 234 · See all- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly227descendants
- K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019 · 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
- K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020 · cites it directly141descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −6 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −5 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| −4 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| −3 | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| −2 | K143126 | Renovis S141 Lumbar Interbody Cage System | Renovis Surgical Technologies | 2015 | — |
| −1 | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP… | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K153105 | MLX™ - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019 | — |
| +3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| +3 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| +1 | K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020 | — |
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 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 1 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 15 | 0 |
| 2021 | 19 | 0 |
| 2022 | 25 | 0 |
| 2023 | 35 | 0 |
| 2024 | 49 | 0 |
| 2025 | 42 | 0 |
| 2026 | 39 | 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? (4)
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 |
|---|---|---|---|
| * | K140770 | MLX - Medial Lateral Expandable Lumbar Interbody SystemSummary page 4…ateral Expandable Lumbar Interbody System is substantially equivalent to the primary predicate device, MLX – Medial Lateral Expandable Lumbar Interbody System (K140770), and additional predicate devices, NuVasive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable… | 2014 |
| * | K130820 | Expandable Lumbar Interbody SystemSummary page 4…cate device, MLX – Medial Lateral Expandable Lumbar Interbody System (K140770), and additional predicate devices, NuVasive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable Lumbar Interbody System (K151374), and NuVasive® CoRoent® Titanium System (K120918). D.… | 2013 |
| * | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Summary page 4…m (K140770), and additional predicate devices, NuVasive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable Lumbar Interbody System (K151374), and NuVasive® CoRoent® Titanium System (K120918). D. Device Description The NuVasive MLX – Medial Lateral Expandable Lu… | 2015 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 4…asive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable Lumbar Interbody System (K151374), and NuVasive® CoRoent® Titanium System (K120918). D. Device Description The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti… | 2012 |
What descends from it? (234)
See all 2343 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 15 companies; a new generation was cleared every 9 months on median.
- 16 of the 113 ancestors have a recall of any class.
- Of its descendants, K172123 (Nu Vasive, Incorporated, 2017) has gone furthest, with 227 descendants of its own.
- 5 other devices also cite its predicate K140770.
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® MLX™ – 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 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 S1, for the treatment of degenerative disc disease (DDD) with…
Read the full statement (160 words)
The NuVasive® MLX™ – 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 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 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX – Medial Lateral Expandable Lumbar Interbody System. The 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/K153105 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153105: MLX™ - Medial Lateral Expandable Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153105
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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