# K180537: Zavation Buttress Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Mar 27, 2018 after 27 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K971730 (1997). 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)
- K081770: Black Widow Anterior Buttress Plate, Omni Surgical, L.P. (2009) Summary page 4.
- K061482: Altes Buttress Plating System, Altiva Corp. (2006) Summary page 5.
- K112533: Zavation Cervical Plate System, Zavation, LLC (2011) Summary page 5.

## Indications for use
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Source page: https://510kreport.com/device/K180537
Methodology: https://510kreport.com/methodology