# K011025: Fortaflex Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Aug 24, 2001 after 141 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.
149 later devices descend from it; 6 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K013625: Permacol (2002), 95 descendants of its own
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own
- K021056: Permacol (2002), 51 descendants of its own

Source page: https://510kreport.com/device/K011025
Methodology: https://510kreport.com/methodology