# K112592: Axle Peek Interspinous Fusion System

- Pathway: 510(k) (Special)
- Applicant: X-Spine Systems, Inc.
- Decided: Dec 5, 2011 after 89 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K130438: Axle Interspinous Fusion System (2013), 18 descendants of its own
- 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

## Indications for use
The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (Ti-Si 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 PEEK Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Source page: https://510kreport.com/device/K112592
Methodology: https://510kreport.com/methodology