# K092483: Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 18, 2009 after 127 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K913469 (1991). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082396: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087, C.R. Bard, Inc. (2009) Summary page 1.

## Most influential descendants
- K132698: Fastouch Fixation System (2014), 3 descendants of its own
- K162252: FasTouch Fixation System (2016), 2 descendants of its own
- K181668: FasTouch Absorbable Fixation System (2019), 1 descendant of its own
- K111153: Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation System (2011), 1 descendant of its own
- K203117: TissueTak device (2021), 0 descendants of its own

## Indications for use
The BARD PERMAFIX FIXATION SYSTEM is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Source page: https://510kreport.com/device/K092483
Methodology: https://510kreport.com/methodology