510(k) · Cleared
ClearedLanx Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 24, 2008 after a 78-day review. The FDA summary names its predicate without a number. 463 later devices descend from it.
- Decided
- Jan 24, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
463 later devices descend from it, 5 citing it directly.
- This deviceK073144 Lanx Intervertebral Body Fusion DeviceLanx, LLC · 2008
- Descendant · cites it directly · 451 of its ownK083815 Lanx Fusion SystemLanx, Inc. · 2009
- Descendant · 2 generations on · 328 of its ownK102738 Lanx Fusion SystemLanx, LLC · 2011 · Recalled
- Descendant · 3 generations on · 324 of its ownK123767 Lanx Fusion System- SALanx, Inc. · 2013 · Recalled
- Descendant · cites it directly · 269 of its ownK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- Descendant · 2 generations on · 265 of its ownK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
Showing 5 of 463 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 463 · See all- K083815Lanx Fusion SystemLanx, Inc. · 2009 · cites it directly451descendants
- K102738Lanx Fusion SystemLanx, LLC · 2011 · 2 generations on328descendants
- K123767Lanx Fusion System- SALanx, Inc. · 2013 · 3 generations on324descendants
- K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013 · cites it directly269descendants
- K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 2 generations on265descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073144 | Lanx Intervertebral Body Fusion Device | Lanx, LLC | 2008 | — |
| +1 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| +2 | K102738 | Lanx Fusion System | Lanx, LLC | 2011 | 1 |
| +3 | K123767 | Lanx Fusion System- SA | Lanx, Inc. | 2013 | 4 |
| +1 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| +2 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 13 | 0 |
| 2018 | 31 | 0 |
| 2019 | 20 | 0 |
| 2020 | 36 | 0 |
| 2021 | 35 | 0 |
| 2022 | 52 | 0 |
| 2023 | 63 | 0 |
| 2024 | 66 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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 |
|---|---|---|---|
| * | — | Zimmer Spine, Inc. BAK Vista Interbody Fusion System Named without a submission number | |
| * | — | DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System Named without a submission number | |
| * | — | Lanx, LLC, Lanx Vertebral Body Replacement Device Named without a submission number |
What descends from it? (463)
See all 4635 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?
- Of its descendants, K083815 (Lanx, Inc., 2009) has gone furthest, with 451 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. 2008, 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 Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a…
Read the full statement (126 words)
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplimental fixation systems include the Lanx Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073144: Lanx Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073144
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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