510(k) Report

510(k) · Cleared

Cleared

Modification to: Lanx Spinal Fixation System

K090252510(k) SpecialCleared Mar 4, 200930-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lanx, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Mar 4, 2009 as substantially equivalent to K043484 (Lanx, LLC, 2005) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 2004. 18 later devices descend from it.

Decided
Mar 4, 2009
Review
30 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K033826 (2004). 6 ancestors in all, the oldest K032037 (2003). 18 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2011: 1 descendant cleared2015: 4 descendants cleared2012: 3 descendants cleared2014: 5 descendants cleared2013: 2 descendants cleared2018: 1 descendant cleared2016: 2 descendants clearedK033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalledK043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K071633 · Lanx Deformity System · Lanx, LLC · 2007200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K071633 · Lanx Deformity System · Lanx, LLC · 2007K043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalled0
  1. Root · 3 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
  2. 2 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
  3. 1 generation backK071633 Lanx Deformity SystemLanx, LLC · 2007
  4. This deviceK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
  5. Descendant · cites it directly · 8 of its ownK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
  6. Descendant · cites it directly · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  7. Descendant · 2 generations on · 5 of its ownK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
  8. Descendant · 2 generations on · 3 of its ownK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
  9. Descendant · 3 generations on · 2 of its ownK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32013: 22014: 52015: 42016: 22018: 1
2011high 5 (2014) · low 0 (2017)2026

Most influential descendants

Showing 5 of 18 · See all
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012 · cites it directly8descendants
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012 · cites it directly6descendants
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014 · 2 generations on5descendants
  • K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014 · 2 generations on3descendants
  • K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC20041
−2K043484Lanx Spinal Fixation SystemLanx, LLC2005—
−1K071633Lanx Deformity SystemLanx, LLC2007—
0 (this device)K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc.2009—
+1K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
+1K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—
+2K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.2014—
+2K142378Interspinous Plate SystemPrecision Spine, Inc.2014—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201320
201450
201540
201620
201810
FIG. 1 — Lineage of K090252, 2004–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043484Lanx Spinal Fixation System
Summary page 1
…Interlaminal Fixation Orthosis 21 CFR 888.3050 Device Class: Class II Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877) Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to be used to help prov…
Lanx, LLC2005—
*K071633Lanx Deformity System
Summary page 1
…Interlaminal Fixation Orthosis 21 CFR 888.3050 Device Class: Class II Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877) Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immob…
Lanx, LLC2007—
*K071877Lanx Spinal Fixation System
Summary page 1
…Interlaminal Fixation Orthosis 21 CFR 888.3050 Device Class: Class II Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877) Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization…
Lanx, LLC2007—

Also cleared against K043484: 5 other devices →

What descends from it? (18)

See all 18

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121940Lanx Spinal Fixation SystemLanx, Inc.20128
K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC20126
K102886CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20112
K121924Integra Interspinous Process SystemSeaspine, Inc.20131
K113157Aileron Interspinous Fixation SystemLife Spine20121
K143631Benefix Interspinous Fixation SystemU&I Corporation20150
K140236Aileron Interspinous Fixation SystemLife Spine, Inc.20140
K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140

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 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K121940 (Lanx, Inc., 2012) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K043484.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—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 (193 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 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.

Also cleared against K043484

5 other devices cite the same predicate.

  • K121924Integra Interspinous Process SystemSeaspine, Inc. · 2013
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012
  • K103237Lanx Spinal SystemLanx, Inc. · 2011
  • K071877Lanx Spinal Fixation SystemLanx, LLC · 2007
  • K071633Lanx Deformity SystemLanx, LLC · 2007

More from Lanx, Inc.

23 FDA decisions under this applicant name. See the company

  • K131547Lanx Fusion SystemLanx, Inc. · 20131 recall
  • K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013
  • K123767Lanx Fusion System- SALanx, Inc. · 20134 recalls
  • K121316Lanx Spinal Fization SystemLanx, Inc. · 2012
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 20121 recall

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K090252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090252: Modification to: 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/K090252

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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