510(k) · Cleared
ClearedLanx Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 16, 2005 as substantially equivalent to K033826 (Orthopedic Alliance, LLC, 2004) after a 150-day review. Its family tree reaches back 1 generation to 2004. 77 later devices descend from it.
- Decided
- May 16, 2005
- Review
- 150 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033826 (2004). 77 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- This deviceK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- Descendant · cites it directly · 75 of its ownK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- Descendant · 2 generations on · 37 of its ownK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- Descendant · 2 generations on · 32 of its ownK102195 SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011
- Descendant · 3 generations on · 30 of its ownK131238 Affix Spinous Process Plate SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 29 of its ownK071633 Lanx Deformity SystemLanx, LLC · 2007
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K071877Lanx Spinal Fixation SystemLanx, LLC · 2007 · cites it directly75descendants
- K100354Primal OK Interspinous Fusion SystemOsteomed LP · 2010 · 2 generations on37descendants
- K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011 · 2 generations on32descendants
- K131238Affix Spinous Process Plate SystemNuvasive, Inc. · 2013 · 3 generations on30descendants
- K071633Lanx Deformity SystemLanx, LLC · 2007 · cites it directly29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| 0 (this device) | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| +1 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| +2 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| +2 | K102195 | SP-Fix Spinous Process Fixation Plate | Globus Medical, Inc. | 2011 | — |
| +3 | K131238 | Affix Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| +1 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K033826 | Orthopedic Alliance Spine SystemSummary page 1…te Device: LANX, LLC. believes that the Lanx Spinal Fixation System is substantially equivalent to the following: a Orthopedic Alliance, LLC, K033826, Orthopedic Alliance Spine System Equivalence can be seen in the design, material composition, surgical technique and in… | 2004 |
What descends from it? (77)
See all 776 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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043484: Lanx Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043484
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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