# K051091: Synthograft

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Sep 1, 2005 after 126 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Synthograft is designed for: the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects the augmentation of the sinus floor the augmentation of the alveolar ridges the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies the preservation of the alveolus for the preparation of an implant site.

Source page: https://510kreport.com/device/K051091
Methodology: https://510kreport.com/methodology