510(k) · Cleared
ClearedLanx Lateral
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 Mar 23, 2011 as substantially equivalent to K083815 (Lanx, Inc., 2009) and 2 other predicates after a 98-day review. Its family tree reaches back 7 generations to 1984. 238 later devices descend from it.
- Decided
- Mar 23, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 28 ancestors in all. 238 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 4 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 3 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 2 generations backK052384 Lanx VBR SystemLanx, LLC · 2005
- 1 generation backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- This deviceK103666 Lanx LateralLanx, Inc. · 2011
- Descendant · cites it directly · 147 of its ownK133557 Juliet LL Lateral Lumbar CageSpineart · 2014
- Descendant · cites it directly · 146 of its ownK141135 Juliet LLSpineart · 2014
- Descendant · 2 generations on · 145 of its ownK161888 JULIET® LL Lateral Lumbar CageSpineart · 2016
- Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- Descendant · 4 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Showing 5 of 238 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 238 · See all- K133557Juliet LL Lateral Lumbar CageSpineart · 2014 · cites it directly147descendants
- K141135Juliet LLSpineart · 2014 · cites it directly146descendants
- K161888JULIET® LL Lateral Lumbar CageSpineart · 2016 · 2 generations on145descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 4 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −4 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −3 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −2 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| −1 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| 0 (this device) | K103666 | Lanx Lateral | Lanx, Inc. | 2011 | — |
| +1 | K133557 | Juliet LL Lateral Lumbar Cage | Spineart | 2014 | — |
| +1 | K141135 | Juliet LL | Spineart | 2014 | — |
| +2 | K161888 | JULIET® LL Lateral Lumbar Cage | Spineart | 2016 | — |
| +3 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| +4 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 15 | 0 |
| 2022 | 29 | 0 |
| 2023 | 37 | 0 |
| 2024 | 39 | 0 |
| 2025 | 43 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | K083815 | Lanx Fusion SystemSummary page 1…ion Name/Regulation Number 21 CFR § 888.3080, Orthosis, spinal intervertebral fusion Predicate Devices Lanx, Inc: Lanx Intervertebral BodyIVBR Fusion Device. (K0838 15) Nuvasive: CoRoent (K07 1795, K052210) Intended Use / Indications for Use When used as a lumbar intervertebral bo… | 2009 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…888.3080, Orthosis, spinal intervertebral fusion Predicate Devices Lanx, Inc: Lanx Intervertebral BodyIVBR Fusion Device. (K0838 15) Nuvasive: CoRoent (K07 1795, K052210) Intended Use / Indications for Use When used as a lumbar intervertebral body fusion device, the Lain Fusion Sy… | 2007 |
| * | K052210 | Nuvasive Coroent Extensure SystemSummary page 1…Orthosis, spinal intervertebral fusion Predicate Devices Lanx, Inc: Lanx Intervertebral BodyIVBR Fusion Device. (K0838 15) Nuvasive: CoRoent (K07 1795, K052210) Intended Use / Indications for Use When used as a lumbar intervertebral body fusion device, the Lain Fusion System-… | 2005 |
What descends from it? (238)
See all 2385 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 27 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K133557 (Spineart, 2014) has gone furthest, with 147 descendants of its own.
- 5 other devices also cite its predicate K083815.
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. 2011, 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 lumbar intervertebral body fusion device; the Lanx Fusion System - Lateral ("Lanx Lateral') 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-SJ. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six…
Read the full statement (292 words)
When used as a lumbar intervertebral body fusion device; the Lanx Fusion System - Lateral ("Lanx Lateral') 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-SJ. 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 Lain Lateral 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 Fusion System - Lateral ("Lain Lateral') 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 Ti to LS) The Lain Lateral may also be used in the thoracolumbar spine (i. e., Ti - LS) 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 Lain Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lain Lateral 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/K103666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103666: Lanx Lateral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103666
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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