# K221399: ZIP™ MIS Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine, Inc.
- Decided: Jul 8, 2022 after 56 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: 6 generations back to K032037 (2003). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141317: Zip Mis Interspinous Fusion System, Aurora Spine, Inc. (2014) Summary page 5.
- 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.
- K213266: Inspan ScrewLES Fusion System, Lespine Innovations, LLC (2021) Summary page 5.

## 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), lumbar spinal stenosis, 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/K221399
Methodology: https://510kreport.com/methodology