# K034039: Sis Plastic Surgery Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Feb 18, 2004 after 51 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). 14 ancestors in all.
93 later devices descend from it; 12 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K070560: LRTM Surgical Mesh (2007), 50 descendants of its own
- K060829: Cosmatrix (2006), 18 descendants of its own
- K071807: Orthomend Soft Tissue Matrix (2007), 17 descendants of its own
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K142326: HP Tissue Matrix (2014), 11 descendants of its own

## Indications for use
The SIS Plastic Surgery Matrix Is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K034039
Methodology: https://510kreport.com/methodology