# K021107: Fortaflex Surgical Sling

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: May 15, 2002 after 40 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: 4 generations back to K921895 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.

## Indications for use
FortaPerm™ is intended for implantation to reinforce and support soft tissues where weakness exists, including but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, the FortaPerm™ may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.

Source page: https://510kreport.com/device/K021107
Methodology: https://510kreport.com/methodology