# K143388: Affix IIS Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 5, 2015 after 99 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). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132411: Affix II Spinous Process Plate System, Nu Vasive, Incorporated (2013) Summary page 4.
- K121940: Lanx Spinal Fixation System, Lanx, Inc. (2012) Summary page 4.
- K130438: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.

## Indications for use
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 – 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 discogenic origin with degeneration of the disc confirmed by history and radiographic studies. • Spondylolisthesis • Trauma (i.e., fracture or dislocation) • Tumor The Affix IIS Spinous Process Plate System is not intended for stand-alone use.

Source page: https://510kreport.com/device/K143388
Methodology: https://510kreport.com/methodology