# K041217: Modification to Bone Graft Washer

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: May 28, 2004 after 18 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073349: Reliance Buttress Washer System (2008), 1 descendant of its own
- K213219: Vy Spine™ VyWasher™ Buttress System (2021), 0 descendants of its own

## Indications for use
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (TI-SI) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

Source page: https://510kreport.com/device/K041217
Methodology: https://510kreport.com/methodology