# K050170: Fortoss Vital Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Aug 26, 2005 after 212 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: 4 generations back to K960978 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040646: Straumann Granules, The Straumann Co. (2004) Summary page 1.
- K910432: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1991) Summary page 1.

## Indications for use
Fortoss Vital ™ is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

Source page: https://510kreport.com/device/K050170
Methodology: https://510kreport.com/methodology