# K133091: Zip Mis Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine
- Decided: Nov 27, 2013 after 58 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: 3 generations back to K032037 (2003). 6 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007)
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 2.

## 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
- K212781: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (2021), 5 descendants of its own

## Indications for use
The Aurora Spine ZIPTAI MIS Interspinlous Fusion System is a posterior. non-pedicle supplemental fixation device. intended for u.se nta Single level in the non-cervical spine (TI -SI). It is intended for plate flxaiion/attachmnein to tile spinlous Process for the purpose of achieving supplemental fusion ill thle f'ollowin± conditions: degenerative disc disease (deflned as back pain ol' discogenic origin wvith degeneration of' the disc confirmed by history and radiographic studies). spondvlolisthiesis. traumna (i.e.. fracture or dislocation), and/or tumor. The Aurora Spine ZI11iNI MIS Inierspinlots Fusion Systemn is intended lfor use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K133091
Methodology: https://510kreport.com/methodology