# K120605: Permacol Surgical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: May 18, 2012 after 80 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: 7 generations back to K881854 (1988). 29 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043366: Permacol Surgical Implant, Tissue Science Laboratories, Plc (2004) Summary page 1.
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold, Tei Biosciences, Inc. (2010) Summary page 1.

## Most influential descendants
- K160181: Colorado Therapeutics Xenograft Implant (2016), 1 descendant of its own
- K133011: Diaphragmatic Hernia Graft (2014), 1 descendant of its own
- K171817: Biodesign Diaphragmatic Hernia Graft (2018), 0 descendants of its own
- K172937: Colorado Therapeutics Xenograft Implant (2017), 0 descendants of its own

## Indications for use
Permacolw Surgical Implant is intended for use as a soft tissue implant 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, inguinal, diaphragmatic, femoral. scrotal, umbilical, incisional, parastomnal hernias, muscle flap reinforcement and abdominal wall defects.

Source page: https://510kreport.com/device/K120605
Methodology: https://510kreport.com/methodology