# K994122: Bone Graft Washer, Model 9090114 - 9090118

- Pathway: 510(k) (Traditional)
- Applicant: Danek Medical, Inc.
- Decided: Feb 18, 2000 after 73 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.
251 later devices descend from it; 2 cite it directly.
0 of 252 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
- K013665: Pyramid Anterior Plate Fixation System (2002), 248 descendants of its own
- K052546: Aegis Anterior Lumbar Plate System (2006), 211 descendants of its own
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System (2005), 211 descendants of its own
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System (2006), 165 descendants of its own
- K070922: Modification to Spinal Usa VBR System (2007), 161 descendants of its own

## Indications for use
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) 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/K994122
Methodology: https://510kreport.com/methodology