# K121924: Integra Interspinous Process System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Sep 4, 2013 after 429 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: 4 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)
- K100407: Life Spine Interspinous Fixation System, Life Spine (2010) Summary page 1.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 2.
- K083581: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 2.
- K043484: Lanx Spinal Fixation System, Lanx, LLC (2005) Summary page 2.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 2.

## Most influential descendants
- K173334: SeaSpine Spinous Process System (2018), 0 descendants of its own

## Indications for use
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to the 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) *spinal tumor The device is not intended for stand-alone use.

Source page: https://510kreport.com/device/K121924
Methodology: https://510kreport.com/methodology