# K082383: Fortoss Vital

- Pathway: 510(k) (Special)
- Applicant: Biocomposites, Ltd.
- Decided: Sep 5, 2008 after 17 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K131385: Easy-Graft (2013), 0 descendants of its own

## 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/K082383
Methodology: https://510kreport.com/methodology