# K020049: Fortaflex Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Mar 18, 2002 after 70 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: 5 generations back to K921895 (1992). 24 ancestors in all.
102 later devices descend from it; 5 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K042809: Cuffpatch (2004), 72 descendants of its own
- K043388: Pegasus Biologics Orthadapt Surgical Mesh (2005), 49 descendants of its own
- K071065: Orthadapt Bioimplant (2007), 44 descendants of its own
- K052830: Sportmesh (2006), 44 descendants of its own
- K053562: Zimmer Collagen Repair Patch (2006), 41 descendants of its own

## Indications for use
FortaFlex™ Surgical Mesh 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 also intended for reinforcement of the soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

Source page: https://510kreport.com/device/K020049
Methodology: https://510kreport.com/methodology