# K140236: Aileron Interspinous Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Oct 20, 2014 after 263 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K033826 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113157: Aileron Interspinous Fixation System, Life Spine (2012) Summary page 4.
- K100407: Life Spine Interspinous Fixation System, Life Spine (2010) Summary page 4.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K140236
Methodology: https://510kreport.com/methodology