# K130438: Axle Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Jun 27, 2013 after 126 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990745 (1999). 26 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101471: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2010) Summary page 2.
- K112592: Axle Peek Interspinous Fusion System, X-Spine Systems, Inc. (2011) Summary page 2.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 2.

## Most influential descendants
- K140046: Spinous Process Fusion (SPF) Plate (2015), 9 descendants of its own
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), 8 descendants of its own
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), 7 descendants of its own
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), 6 descendants of its own
- K212781: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (2021), 5 descendants of its own

## Recalls of this device
- Dec 29, 2021 · Class II · Z-0533-2022: The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

## Indications for use
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment 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 Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Source page: https://510kreport.com/device/K130438
Methodology: https://510kreport.com/methodology