510(k) · Cleared
ClearedLanx Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 20, 2009 as substantially equivalent to K073144 (Lanx, LLC, 2008) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1984. 451 later devices descend from it.
- Decided
- Apr 20, 2009
- Review
- 119 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K841189 (1984). 15 ancestors in all. 451 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 3 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 2 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 1 generation backK052384 Lanx VBR SystemLanx, LLC · 2005
- This deviceK083815 Lanx Fusion SystemLanx, Inc. · 2009
- Descendant · cites it directly · 328 of its ownK102738 Lanx Fusion SystemLanx, LLC · 2011 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 254 of its ownK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
Showing 5 of 451 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 451 · See all- K102738Lanx Fusion SystemLanx, LLC · 2011 · cites it directly328descendants
- K123767Lanx Fusion System- SALanx, Inc. · 2013 · 2 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
- K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 3 generations on254descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −3 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −2 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −1 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| 0 (this device) | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| +1 | K102738 | Lanx Fusion System | Lanx, LLC | 2011 | 1 |
| +2 | 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 | — |
| +3 | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 13 | 0 |
| 2018 | 27 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 35 | 0 |
| 2022 | 51 | 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 |
|---|---|---|---|
| * | K073144 | Lanx Intervertebral Body Fusion DeviceSummary page 1…is, 21 CFR 888.3060 Regulatory Class Class 1I Product Codes ODP, MAX, MQP Predicate Devices Lanx, Inc: Lanx Intervertebral Body Fusion Device (K073 144) Lain, fIc: LainVBR (K0523 84) Lain, Inc: Lanx Cervical Intervertebral Body Fusion Device. (K082774) Other Similar… | 2008 |
| * | K052384 | Lanx VBR SystemSummary page 1…Class 1I Product Codes ODP, MAX, MQP Predicate Devices Lanx, Inc: Lanx Intervertebral Body Fusion Device (K073 144) Lain, fIc: LainVBR (K0523 84) Lain, Inc: Lanx Cervical Intervertebral Body Fusion Device. (K082774) Other Similar Devices: Medtronic Sofamor D… | 2005 |
| * | K082774 | Lanx Cervical Intervertebral Body Fusion DeviceSummary page 1…Lanx, Inc: Lanx Intervertebral Body Fusion Device (K073 144) Lain, fIc: LainVBR (K0523 84) Lain, Inc: Lanx Cervical Intervertebral Body Fusion Device. (K082774) Other Similar Devices: Medtronic Sofamor Danek: CAPSTONE® Spinal System (K073291) Stryker Spine: AVS PL PEEK Spa… | 2008 |
| † | K073291 | Capstone Spinal System | 2008 |
| † | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | 2008 |
| † | K080699 | Novel Spinal Spacer System | 2008 |
What descends from it? (451)
See all 4516 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 25 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K102738 (Lanx, LLC, 2011) has gone furthest, with 328 descendants of its own.
- 4 other devices also cite its predicate K073144.
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. 2009, 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?
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (430 words)
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. 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 1 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 supplemental fixation systems include the Lanx Spinal Fixation System.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083815: Lanx Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083815
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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