# K191287: OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

- Pathway: 510(k) (Special)
- Applicant: Davol Inc., Subsidiary of C.R. Bard
- Decided: Jul 16, 2019 after 64 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: 7 generations back to K913469 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170278: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners, C.R. Bard, Inc. (2017) Summary page 4.

## Indications for use
The OptiFix AT Absorbable Fixation System with Articulating Technology 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/K191287
Methodology: https://510kreport.com/methodology