# K131238: Affix Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jul 2, 2013 after 62 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.
30 later devices descend from it; 6 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010)

## Most influential descendants
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), 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 Affix Spinous Process Plate System 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 process 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) *Tumor The Affix Spinous Process Plate System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K131238
Methodology: https://510kreport.com/methodology