# K163698: OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 11, 2017 after 103 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: 6 generations back to K913469 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners, C.R. Bard, Inc. (2015) Summary page 4.

## Indications for use
The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.

Source page: https://510kreport.com/device/K163698
Methodology: https://510kreport.com/methodology