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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 6, 2010 after a 123-day review. The FDA summary names its predicate without a number. 34 later devices descend from it.
- Decided
- Aug 6, 2010
- Review
- 123 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 5 citing it directly.
- This deviceK100935 Lanx Spinal Fixation SystemLanx, Inc. · 2010
- Descendant · cites it directly · 18 of its ownK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK103237 Lanx Spinal SystemLanx, Inc. · 2011
- Descendant · 2 generations on · 17 of its ownK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- Descendant · 2 generations on · 12 of its ownK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- Descendant · 3 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012 · cites it directly18descendants
- K103237Lanx Spinal SystemLanx, Inc. · 2011 · cites it directly18descendants
- K120399Lanx Spinal Fixation SystemLanx, LLC · 2012 · 2 generations on17descendants
- K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013 · 2 generations on12descendants
- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100935 | Lanx Spinal Fixation System | Lanx, Inc. | 2010 | — |
| +1 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| +1 | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| +2 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| +2 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| +3 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Lanx Spinal Fixation System Named without a submission number |
What descends from it? (34)
See all 345 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, K122509 (Vertiflex, Inc., 2012) has gone furthest, with 18 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (TL-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in…
Read the full statement (219 words)
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.
The Lanx Spinal Fixation System is intended for posterior, non-cervical (TL-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (Ti-Si1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100935: 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/K100935
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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