# K142213: Via Spinous Process Fixation System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Sep 10, 2014 after 29 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: 6 generations back to K033826 (2004). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123232: Spineology Spinous Process Plate, Spineology, Inc. (2013) Summary page 4.

## Indications for use
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - Sl). It is intended for plate fixation/attachment to spinous process 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. • Trauma (i.e., fracture or dislocation) • Spondylolisthesis • Tumor The VIA™ Spinous Process Fixation System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K142213
Methodology: https://510kreport.com/methodology