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 Sep 17, 2007 as substantially equivalent to K043484 (Lanx, LLC, 2005) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 2003. 75 later devices descend from it.
- Decided
- Sep 17, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K032037 (2003). 4 ancestors in all. 75 later devices descend from it, 18 citing it directly.
- Root · 2 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 1 generation backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- This deviceK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- Descendant · cites it directly · 37 of its ownK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- Descendant · cites it directly · 32 of its ownK102195 SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011
- Descendant · 2 generations on · 30 of its ownK131238 Affix Spinous Process Plate SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 18 of its ownK133052 Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 18 of its ownK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K100354Primal OK Interspinous Fusion SystemOsteomed LP · 2010 · cites it directly37descendants
- K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011 · cites it directly32descendants
- K131238Affix Spinous Process Plate SystemNuvasive, Inc. · 2013 · 2 generations on30descendants
- K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013 · 3 generations on18descendants
- K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −1 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| +1 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| +1 | K102195 | SP-Fix Spinous Process Fixation Plate | Globus Medical, Inc. | 2011 | — |
| +2 | K131238 | Affix Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| +3 | K133052 | Affix (R) Next Gen Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| +1 | K130438 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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…inal Interlaminal Fixation Orthosis (KWP) 21 C.F.R. § 888.3070 and/or 21 C.F.R. § 888.3050 Predicate Devices Lanx Spinal Fixation System (K043484) Medtronic Sofamor Danek CD Horizon Spinal System (K043053) 16 La"x 510… | 2005 |
| * | K043053 | Modification to CD Horizon Spinal SystemSummary page 1….R. § 888.3070 and/or 21 C.F.R. § 888.3050 Predicate Devices Lanx Spinal Fixation System (K043484) Medtronic Sofamor Danek CD Horizon Spinal System (K043053) 16 La"x 510(1) Submission Intended Use / Indications for Use… | 2005 |
What descends from it? (75)
See all 7518 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100354 | Primal OK Interspinous Fusion System | 2010 | 37 |
| K102195 | SP-Fix Spinous Process Fixation Plate | 2011 | 32 |
| K130438 | Axle Interspinous Fusion System | 2013 | 18 |
| K122509 | Vertiflex Spinous Process Fixation Plate | 2012 | 18 |
| K103237 | Lanx Spinal System | 2011 | 18 |
| K090252 | Modification to: Lanx Spinal Fixation System | 2009 | 18 |
| K133091 | Zip Mis Interspinous Fusion System | 2013 | 14 |
| K140046 | Spinous Process Fusion (SPF) Plate | 2015 | 9 |
| K121940 | Lanx Spinal Fixation System | 2012 | 8 |
| K102020 | Vega Span Spinous Process Plate System | 2010 | 8 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K100354 (Osteomed LP, 2010) has gone furthest, with 37 descendants of its own.
- 5 other devices also cite its predicate K043484.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 (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 Lanx SFS 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…
Read the full statement (191 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 Lanx SFS 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).
The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). 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 and is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071877: Lanx Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071877
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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