# K013625: Permacol

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Jan 17, 2002 after 73 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: 1 generation back to K973379 (1997). 6 ancestors in all.
95 later devices descend from it; 9 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 2.
- K002071: Softform Soft Tissue Augmentation Tube with Insertion Tool Modifications for Strands and Suture Holes, Tissue Technologies, Inc. (2000) Summary page 2.
- K000849: Softform Facial Implant, Tissue Technologies, Inc. (2000) Summary page 2.
- K973462: Softform Facial Implant, Tissue Technologies, Inc. (1997) Summary page 2.
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001) Summary page 2.
- K973379: Sterile Suprafoil Smooth Nylon Foil Sheets, S. Jackson, Inc. (1997) Summary page 2.

## Most influential descendants
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own
- 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

## Indications for use
Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for plastic and reconstructive surgery of the face and head.

Source page: https://510kreport.com/device/K013625
Methodology: https://510kreport.com/methodology