# K213219: Vy Spine™ VyWasher™ Buttress System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Dec 23, 2021 after 85 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: 4 generations back to K926453 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073349: Reliance Buttress Washer System, Reliance Medical Systems, LLC (2008) Summary page 4.

## Indications for use
The Vy Spine™ VyWasher™ Buttress System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K213219
Methodology: https://510kreport.com/methodology