# K111153: Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 24, 2011 after 29 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: 5 generations back to K913469 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K092483: Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018, C.R. Bard, Inc. (2009) Summary page 1.

## Most influential descendants
- K123718: Permasorb Disposable Fixation Device (2013), 0 descendants of its own

## Indications for use
The SorbaFix Absorbable 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. The 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/K111153
Methodology: https://510kreport.com/methodology