# K050246: Sis Dermal Augmentation Strand

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: May 19, 2005 after 106 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). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002)
- K992991: Atrium Medical Corporation Advanta Ptfe Facial Implant, Atrium Medical Corp. (2000) Summary page 1.

## Most influential descendants
- K053622: Surgisis Ocular Graft (2006), 2 descendants of its own
- K090078: Kerasys Bioengineered Lamellar Patch Graft (2009), 1 descendant of its own
- K223074: CorNeat EverPatch (2023), 0 descendants of its own
- K110402: Biodesign Nipple Reconstruction Cylinder (2011), 0 descendants of its own

## Indications for use
The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K050246
Methodology: https://510kreport.com/methodology