510(k) · Cleared
ClearedLanx Deformity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 15, 2007 as substantially equivalent to K043484 (Lanx, LLC, 2005) after a 62-day review. Its family tree reaches back 2 generations to 2004. 29 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033826 (2004). 29 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 1 generation backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- This deviceK071633 Lanx Deformity SystemLanx, LLC · 2007
- Descendant · cites it directly · 18 of its ownK103237 Lanx Spinal SystemLanx, Inc. · 2011
- Descendant · cites it directly · 18 of its ownK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
- Descendant · 2 generations on · 17 of its ownK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- Descendant · cites it directly · 8 of its ownK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K103237Lanx Spinal SystemLanx, Inc. · 2011 · cites it directly18descendants
- K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009 · cites it directly18descendants
- K120399Lanx Spinal Fixation SystemLanx, LLC · 2012 · 2 generations on17descendants
- K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012 · cites it directly8descendants
- K122145Lanx Spinal Fixation SystemLanx, Inc. · 2012 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −1 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| 0 (this device) | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| +1 | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| +1 | K090252 | Modification to: Lanx Spinal Fixation System | Lanx, Inc. | 2009 | — |
| +2 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| +1 | K121940 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| +3 | K122145 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 KWP? 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 |
|---|---|---|---|
| * | K043484 | Lanx Spinal Fixation SystemSummary page 1…dicle Screw Spinal System 21 CFR §888.3070 Predicate Device Information K043484 Lanx Spinal Fixation System Predicate Device Identification The Lanx Spinal Fixation System is a posterior attachment pedicle f… | 2005 |
What descends from it? (29)
See all 293 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 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K103237 (Lanx, Inc., 2011) has gone furthest, with 18 descendants of its own.
- 5 other devices also cite its predicate K043484.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in sheletally 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/K071633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071633: Lanx Deformity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071633
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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