# K132411: Affix II Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 20, 2013 after 110 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: 1 generation back to K073278 (2008). 1 ancestor in all.
20 later devices descend from it; 3 cite it directly.
0 of 22 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.

## Cited in the summary but kept off the family tree
- K031238: Varices Needle, Scandimed. A.S. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), 18 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
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), 6 descendants of its own

## Indications for use
The Affix 11 Spinous Process Plate System 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 process for the purpose of achieving supplemental fusion in the following conditions: * Degenerative disc disease (DDD) - defined as back pain of discagenic origin with degeneration of the disc confirmed by history and radiographic studies. * Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Tumor The Affix I/ Spinous Process Plate System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K132411
Methodology: https://510kreport.com/methodology