# K043366: Permacol Surgical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Dec 17, 2004 after 9 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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). 12 ancestors in all.
74 later devices descend from it; 5 cite it directly.
0 of 87 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 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K042026: Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004, C.R. Bard, Inc. (2004) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998)
- (no number) Peri-Guard®: named in the summary without a submission number

## Most influential descendants
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 (2005), 54 descendants of its own
- K070560: LRTM Surgical Mesh (2007), 50 descendants of its own
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K080442: Seriscaffold Surgical Mesh (2008), 14 descendants of its own
- K142326: HP Tissue Matrix (2014), 11 descendants of its own

## Indications for use
Permacol® is intended of 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 the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Source page: https://510kreport.com/device/K043366
Methodology: https://510kreport.com/methodology