# K102195: SP-Fix Spinous Process Fixation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 19, 2011 after 168 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- 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.
32 later devices descend from it; 7 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.

## Most influential descendants
- K122509: Vertiflex Spinous Process Fixation Plate (2012), 18 descendants of its own
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM) (2013), 12 descendants of its own
- K140046: Spinous Process Fusion (SPF) Plate (2015), 9 descendants of its own
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), 8 descendants of its own
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), 7 descendants of its own

## Indications for use
The SP-FixTM 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-FiXTM 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/K102195
Methodology: https://510kreport.com/methodology