# K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Mar 7, 2018 after 47 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: 9 generations back to K000319 (2000). 115 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 121 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 5.
- K132191: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2013) Summary page 5.
- K080664: Relieve Laminoplasty Fixation System, Globus Medical, Inc. (2008) Summary page 5.
- K171413: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System, Globus Medical, Inc. (2017) Summary page 5.
- K163471: Kalitec Direct InSePtion™ MIS Fixation System, Kalitec Direct, LLC (2017) Summary page 5.

## Most influential descendants
- 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
- K211205: Prase-C Anterior Cervical Plate System (2021), 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 (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), and/or tumor. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use. The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.

Source page: https://510kreport.com/device/K180156
Methodology: https://510kreport.com/methodology