# K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 12, 2015 after 162 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.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132134: Optifix Absorbable Fixation System, C.R. Bard, Inc. (2013) Summary page 4.

## Most influential descendants
- K170278: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners (2017), 1 descendant of its own
- K191287: OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners (2019), 0 descendants of its own
- K163698: OptiFix Open Absorbable Fixation System - 20 absorbable fasteners (2017), 0 descendants of its own

## Indications for use
The OptiFix™ 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.

Source page: https://510kreport.com/device/K142873
Methodology: https://510kreport.com/methodology