510(k) Report

510(k) · Cleared

Cleared

Modification to Lanx Spinal Fixation System

K093285510(k) SpecialCleared Dec 10, 200951-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, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 10, 2009 after a 51-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.

Decided
Dec 10, 2009
Review
51 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

19 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 4 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK093285 Modification to Lanx Spinal Fixation SystemLanx, LLC · 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 · 2 generations on · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011: 12012: 42014: 22015: 42016: 22017: 22018: 12020: 12026: 2
2011high 4 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · 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 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K093285Modification to Lanx Spinal Fixation SystemLanx, LLC2009—
+1K103237Lanx Spinal SystemLanx, Inc.2011—
+2K120399Lanx Spinal Fixation SystemLanx, LLC2012—
+1K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.20121
+2K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201240
201420
201540
201620
201720
201810
202010
202620
FIG. 1 — Lineage of K093285, 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 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
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? (19)

See all 19

2 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

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 MNI devices

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

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The Lanx Spinal Fixation System (SES) 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. Thle 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 (194 words)

The Lanx Spinal Fixation System (SES) 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.

Thle 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 sponidylolisthesis (grades 3 and 4) of the L5-S I 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-Si1). It is intended for plate fixation/attachmient 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, LLC

13 FDA decisions under this applicant name. See the company

  • K120399Lanx Spinal Fixation SystemLanx, LLC · 2012
  • K102738Lanx Fusion SystemLanx, LLC · 20111 recall
  • K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2011
  • K082774Lanx Cervical Intervertebral Body Fusion DeviceLanx, LLC · 2008
  • K073144Lanx Intervertebral Body Fusion DeviceLanx, LLC · 2008

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K093285 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093285: 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/K093285

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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