# K130066: Spectrum Spine Spinous Process Device

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine IP Holdings, LLC
- Decided: Nov 12, 2013 after 306 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: 3 generations back to K032037 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.
- K112592: Axle Peek Interspinous Fusion System, X-Spine Systems, Inc. (2011) Summary page 1.

## Indications for use
The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (Ti-Si inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.

Source page: https://510kreport.com/device/K130066
Methodology: https://510kreport.com/methodology