# K141317: Zip Mis Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine, Inc.
- Decided: Nov 17, 2014 after 181 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). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140715: Zip Mis Interspinous Fusion System, Aurora Spine, Inc. (2014) Summary page 5.
- K133091: Zip Mis Interspinous Fusion System, Aurora Spine (2013) Summary page 5.

## Most influential descendants
- K221399: ZIP™ MIS Interspinous Fusion System (2022), 0 descendants of its own
- K173334: SeaSpine Spinous Process System (2018), 0 descendants of its own

## Indications for use
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use 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 (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 Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K141317
Methodology: https://510kreport.com/methodology