# K192452: Lyograft

- Pathway: 510(k) (Traditional)
- Applicant: B. Bruan Surgical, SA
- Decided: Sep 3, 2020 after 360 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K091142 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091142: Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358, Rti Biologics, Inc. (2009) Summary page 4.

## Indications for use
Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.

Source page: https://510kreport.com/device/K192452
Methodology: https://510kreport.com/methodology