# K980431: Surgisis

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: May 28, 1998 after 113 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: 2 generations back to K921895 (1992). 5 ancestors in all.
284 later devices descend from it; 29 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961810: Supple Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.
- K970561: Graft Patch, Organogenesis, Inc. (1997) Summary page 1.
- K830889: Dexon 'S' Polyglycolic Acid Mesh, Davis & Geck, Inc. (1983) Summary page 1.

## Most influential descendants
- K992159: Surgisis Sling (1999), 204 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own
- K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant (1998), 92 descendants of its own

## Indications for use
SurgiSIS™ is intended for implantation to reinforce soft tissue. This device is intended for one-time use.

Source page: https://510kreport.com/device/K980431
Methodology: https://510kreport.com/methodology