510(k) · Cleared
ClearedAileron Interspinous Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · PEK Spinous Process Plate
Cleared on Oct 20, 2014 as substantially equivalent to K113157 (Life Spine, 2012) and 2 other predicates after a 263-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Oct 20, 2014
- Review
- 263 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K033826 (2004). 9 ancestors in all, the oldest K032037 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 4 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 3 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 2 generations backK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
- 1 generation backK113157 Aileron Interspinous Fixation SystemLife Spine · 2012
- This deviceK140236 Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −4 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −3 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −2 | K090252 | Modification to: Lanx Spinal Fixation System | Lanx, Inc. | 2009 | — |
| −1 | K113157 | Aileron Interspinous Fixation System | Life Spine | 2012 | — |
| 0 (this device) | K140236 | Aileron Interspinous Fixation System | Life Spine, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 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 PEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEK device
- #1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113157 | Aileron Interspinous Fixation SystemSummary page 4…ication: PEK, 888.3050, Class II, Spinal interlaminal fixation orthosis Predicate Device: Primary Predicate: Aileron Interspinous Fixation System (K113157) Additional Predicates: Life Spine Interspinous Fixation System (K100407),… | 2012 |
| * | K100407 | Life Spine Interspinous Fixation SystemSummary page 4…Primary Predicate: Aileron Interspinous Fixation System (K113157) Additional Predicates: Life Spine Interspinous Fixation System (K100407), Lanx Spinal Fixation System (K090252) Device Description: The Aileron Interspinous Fixation Sys… | 2010 |
| * | K090252 | Modification to: Lanx Spinal Fixation SystemSummary page 4…(K113157) Additional Predicates: Life Spine Interspinous Fixation System (K100407), Lanx Spinal Fixation System (K090252) Device Description: The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, inten… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PEK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEK
60in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEK
3in 2025
MAUDE reports naming product code PEK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 10 | 118 | 0 | 0 |
| 2014 | 8 | 120 | 0 | 2 |
| 2015 | 6 | 166 | 0 | 3 |
| 2016 | 4 | 176 | 0 | 0 |
| 2017 | 3 | 94 | 0 | 0 |
| 2018 | 4 | 69 | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 2 | — | 1 | 17 |
| 2022 | 3 | 135 | 0 | 11 |
| 2023 | 4 | 60 | 0 | 8 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 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 (T1-S1). It is intended for plate fixation/attachment…
Read the full statement (139 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 (T1-S1). It is intended for plate fixation/attachment to the spinous processes in skeletally mature patients for the purpose of achieving, in conjunction with autogenous 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140236: 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/K140236
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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