# K132765: PFX Spinous Process Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jul 14, 2014 after 313 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: 10 generations back to K040583 (2004). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.
- K123246: CD Horizon Spire Z Spinal System, Medtronic Sofamor Danek (2012) Summary page 1.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K133052: Affix (R) Next Gen Spinous Process Plate System, Nuvasive, Inc. (2013). Cleared while this submission was under review Summary page 1.

## Indications for use
The Innovasis PFX Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions: * Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies * Trauma: fracture or dislocation * Spondylolisthesis * Tumor

Source page: https://510kreport.com/device/K132765
Methodology: https://510kreport.com/methodology