# K113157: Aileron Interspinous Fixation System

- Pathway: 510(k) (Special)
- Applicant: Life Spine
- Decided: Mar 13, 2012 after 139 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K033826 (2004). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100407: Life Spine Interspinous Fixation System, Life Spine (2010) Summary page 1.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K140236: Aileron Interspinous Fixation System (2014), 0 descendants of its own

## 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 (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.

Source page: https://510kreport.com/device/K113157
Methodology: https://510kreport.com/methodology