# K123232: Spineology Spinous Process Plate

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Feb 7, 2013 after 114 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
Longest line of descent: 5 generations back to K033826 (2004). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.
- K043053: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.
- K102886: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2011) Summary page 1.
- K103091: Lanx Spinal Fixation System, Lanx, Inc. (2011) Summary page 1.

## Most influential descendants
- K142213: Via Spinous Process Fixation System (2014), 0 descendants of its own

## Indications for use
The Spineology Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (TI - SI). It is intended for single level 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 Spineology Spinous Process Plate is not intended for stand-alone use.

Source page: https://510kreport.com/device/K123232
Methodology: https://510kreport.com/methodology