# K132968: Univise Spinous Process Fixation Plate (35MM, 40MM)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Nov 18, 2013 after 56 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: 7 generations back to K990745 (1999). 32 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 1.
- K122509: Vertiflex Spinous Process Fixation Plate, Vertiflex, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), 6 descendants of its own
- K212781: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (2021), 5 descendants of its own

## Indications for use
The UniViseTM 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 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 UniViSeTM Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K132968
Methodology: https://510kreport.com/methodology