# K132191: SP-Fix Spinous Process Fixation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Nov 22, 2013 after 130 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 K032037 (2003). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 1.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (2018), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K233735: ADIRA™ Lateral Plate System (2024), 0 descendants of its own

## Indications for use
The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, 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), and/or tumor. The SP-Fix® Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K132191
Methodology: https://510kreport.com/methodology