# K021105: Fortaflex Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: May 10, 2002 after 35 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: 3 generations back to K921895 (1992). 6 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970561: Graft Patch, Organogenesis, Inc. (1997) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K033671: Gore Bioabsorbable Mesh (2003), 39 descendants of its own
- K071016: Depuy Restore Orthobiologic Soft Tissue Implant (2007), 13 descendants of its own
- K083266: Gore Bio-a Fistula Plug (2009), 12 descendants of its own
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own
- K120019: Collagen Ribbon (2012), 11 descendants of its own

## Indications for use
FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Source page: https://510kreport.com/device/K021105
Methodology: https://510kreport.com/methodology