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. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 24, 2013 as substantially equivalent to K121316 (Lanx, Inc., 2012) after a 30-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.
- Decided
- May 24, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032037 (2003). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 4 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 2 generations backK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- 1 generation backK121316 Lanx Spinal Fization SystemLanx, Inc. · 2012
- This deviceK131156 Lanx Spinal Fixation SystemLanx, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −4 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −2 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| −1 | K121316 | Lanx Spinal Fization System | Lanx, Inc. | 2012 | — |
| 0 (this device) | K131156 | Lanx Spinal Fixation System | Lanx, Inc. | 2013 | — |
| +1 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K121316 | Lanx Spinal Fization SystemSummary page 1…Interlamninal Fixation Orthosis (per 21 CFR 888.3050 and/or 888.3070) Product Code: KWP Predicate Device Information K121316 Lanx Spinal Fixation System Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to b… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero… | 2020 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K202309 (Zimmer Biomet Spine, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121316.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 (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 allografi. The Lanx Spinal Fixation System is intended for posterior, non-cervical (TI-52/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 allografi.
The Lanx Spinal Fixation System is intended for posterior, non-cervical (TI-52/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 (DOD, 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-SI). 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/K131156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131156: Lanx Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131156
Report an extraction error
Are you the manufacturer?
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