# K123114: Ethicon Securestrap Open Absorbable Strap Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 5, 2013 after 125 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 K951658 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093845: Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25, ETHICON, Inc. (2010) Summary page 1.

## Indications for use
The ETHICON SECURESTRAP Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.

Source page: https://510kreport.com/device/K123114
Methodology: https://510kreport.com/methodology