510(k) Report

510(k) · Cleared

Cleared

Lanx Spinal Fixation System

K083581510(k) SpecialCleared Apr 7, 2009124-day reviewClass II21 CFR 888.3070

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

Lanx, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Apr 7, 2009 after a 124-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
Apr 7, 2009
Review
124 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

21 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 4 descendants cleared2013: 1 descendant cleared2018: 2 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK083581 Lanx Spinal Fixation SystemLanx, Inc. · 2009
  2. Descendant · cites it directly · 18 of its ownK103237 Lanx Spinal SystemLanx, Inc. · 2011
  3. Descendant · 2 generations on · 17 of its ownK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
  4. Descendant · cites it directly · 8 of its ownK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
  5. Descendant · 3 generations on · 7 of its ownK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
  6. Descendant · cites it directly · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2011: 12012: 42013: 12014: 22015: 42016: 22017: 22018: 22020: 12026: 2
2011high 4 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 21 · See all
  • K103237Lanx Spinal SystemLanx, Inc. · 2011 · 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
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083581Lanx Spinal Fixation SystemLanx, Inc.2009—
+1K103237Lanx Spinal SystemLanx, Inc.2011—
+2K120399Lanx Spinal Fixation SystemLanx, LLC2012—
+1K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.20121
+1K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201240
201310
201420
201540
201620
201720
201820
202010
202620
FIG. 1 — Lineage of K083581, 2009–2026Source: 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 MNH? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Lanx Spinal Fixation System
Named without a submission number
—

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K103237Lanx Spinal SystemLanx, Inc.201118
K121940Lanx Spinal Fixation SystemLanx, Inc.20128
K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC20126
K121924Integra Interspinous Process SystemSeaspine, Inc.20131

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, K103237 (Lanx, Inc., 2011) has gone furthest, with 18 descendants of its own.

How does its category compare?

All MNH devices

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

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
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 (189 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, not intended for stand-alone use.

Indications for use as stated in the FDA summary.

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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K083581 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083581: 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/K083581

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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