# K091142: Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

- Pathway: 510(k) (Special)
- Applicant: Rti Biologics, Inc.
- Decided: Aug 31, 2009 after 133 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
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
- K192452: Lyograft (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K091142
Methodology: https://510kreport.com/methodology