# K040783: Foundation

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Oct 13, 2004 after 201 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974399 (1998). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 5.

## Most influential descendants
- K150079: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block (2015), 0 descendants of its own
- K111087: Foundation (2011), 0 descendants of its own
- K083742: Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix (2009), 0 descendants of its own

## Indications for use
The FOUNDATION device is a collagen-based bone filling augmentation material for use in the filling of extraction sockets.

Source page: https://510kreport.com/device/K040783
Methodology: https://510kreport.com/methodology