510(k) Report

510(k) · Cleared

Cleared

Aileron Interspinous Fixation System

K113157510(k) SpecialCleared Mar 13, 2012139-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

Life Spine · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Mar 13, 2012 as substantially equivalent to K100407 (Life Spine, 2010) and 2 other predicates after a 139-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.

Decided
Mar 13, 2012
Review
139 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K033826 (2004). 8 ancestors in all, the oldest K032037 (2003). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2003: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2014: 1 descendant clearedK033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalledK043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K071633 · Lanx Deformity System · Lanx, LLC · 2007K090252 · Modification to: Lanx Spinal Fixation System · Lanx, Inc. · 2009200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant K090252 · Modification to: Lanx Spinal Fixation System · Lanx, Inc. · 2009K071633 · Lanx Deformity System · Lanx, LLC · 2007K043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalled0
  1. Root · 4 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
  2. 3 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
  3. 2 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
  4. 1 generation backK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
  5. This deviceK113157 Aileron Interspinous Fixation SystemLife Spine · 2012
  6. Descendant · cites it directly · 0 of its ownK140236 Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K140236Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC20041
−3K043484Lanx Spinal Fixation SystemLanx, LLC2005—
−2K071633Lanx Deformity SystemLanx, LLC2007—
−1K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc.2009—
0 (this device)K113157Aileron Interspinous Fixation SystemLife Spine2012—
+1K140236Aileron Interspinous Fixation SystemLife Spine, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K113157, 2004–2014Source: 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
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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
*K100407Life Spine Interspinous Fixation System
Summary page 1
…l System KWP, 888.3050, Class II, Spinal Interlaminal Fixation Orthosis Predicate Device: Life Spine Interspinous Fixation System (K 100407), Lanx Spinal Fixation System (K090252) and the CD HORIZON Spinous Process Plate…
Life Spine2010—
*K090252Modification to: Lanx Spinal Fixation System
Summary page 1
…Interlaminal Fixation Orthosis Predicate Device: Life Spine Interspinous Fixation System (K 100407), Lanx Spinal Fixation System (K090252) and the CD HORIZON Spinous Process Plate (K032037) Device Description: The Aileron Interspinous…
Lanx, Inc.2009—
*K032037CD Horizon (Addition of Spinous Process Plate)
Summary page 1
…inous Fixation System (K 100407), Lanx Spinal Fixation System (K090252) and the CD HORIZON Spinous Process Plate (K032037) Device Description: The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device; inte…
Medtronic Sofamor Danek2003—

Also cleared against K100407: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140236Aileron Interspinous Fixation SystemLife Spine, 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 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K140236 (Life Spine, Inc., 2014) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K100407.

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. 2012, 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?

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-Si). It is intended for plate fixation/attachment…

Read the full statement (263 words)

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-Si). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogetious bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.

The ARX® Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5)-fhiled previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Indications for use as stated in the FDA summary.

Also cleared against K100407

2 other devices cite the same predicate.

  • K140236Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014
  • K121924Integra Interspinous Process SystemSeaspine, Inc. · 2013

More from Life Spine

36 FDA decisions under this applicant name. See the company

  • K182470Plateau Spacer SystemLife Spine · 2018
  • K160169The Life Spine Subtalar Implant SystemLife Spine · 2016
  • K150368Tarsa-Link Wedge Fixation SystemLife Spine · 2015
  • K141905Pro-Link Wedge SystemLife Spine · 2014
  • K133717Longbow Spacer SystemLife Spine · 2014

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/K113157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113157: Aileron Interspinous 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/K113157

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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