# K093845: Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Apr 7, 2010 after 113 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951658 (1995). 5 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091900: Absorbatack 5MM Single Use Absorbable Fixation Device, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.

## Most influential descendants
- K132698: Fastouch Fixation System (2014), 3 descendants of its own
- K131635: Rotation Medical Bone Staple (RMB Staple) (2013), 3 descendants of its own
- K162252: FasTouch Fixation System (2016), 2 descendants of its own
- K223860: Integrity™ Bone Staple Fixation System (2023), 1 descendant of its own
- K181668: FasTouch Absorbable Fixation System (2019), 1 descendant of its own

## Recalls of this device
- Dec 29, 2010 · Not classified · Z-1260-2011: The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.

## Indications for use
The ETHICON SECURESTRAPTM 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repair.

Source page: https://510kreport.com/device/K093845
Methodology: https://510kreport.com/methodology