# K173334: SeaSpine Spinous Process System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Feb 22, 2018 after 122 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 K032037 (2003). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121924: Integra Interspinous Process System, Seaspine, Inc. (2013) Summary page 5.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 5.
- K121316: Lanx Spinal Fization System, Lanx, Inc. (2012) Summary page 5.
- K141317: Zip Mis Interspinous Fusion System, Aurora Spine, Inc. (2014) Summary page 5.

## Indications for use
The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). 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 SeaSpine Spinous Process System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K173334
Methodology: https://510kreport.com/methodology