# K111087: Foundation

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Terumo Biomaterials Corporation
- Decided: Nov 29, 2011 after 224 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: 2 generations back to K974399 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040783: Foundation, Terumo Corp. (2004) Summary page 1.

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

Source page: https://510kreport.com/device/K111087
Methodology: https://510kreport.com/methodology