# K133052: Affix (R) Next Gen Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Dec 20, 2013 after 84 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: 5 generations back to K032037 (2003). 9 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 28 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.
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 1.
- K132411: Affix II Spinous Process Plate System, Nu Vasive, Incorporated (2013). Cleared while this submission was under review 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
- K163471: Kalitec Direct InSePtion™ MIS Fixation System (2017), 6 descendants of its own

## Indications for use
The Affix Next Gen 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 - SI1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fuision in the following conditions: - Degenerative disc disease (DDD) - 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 Next Gen Spinous Process Plate System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K133052
Methodology: https://510kreport.com/methodology