# K132669: Proxifast Absorbable Staple

- Pathway: 510(k) (Traditional)
- Applicant: Surgimatix, Inc.
- Decided: Jan 13, 2014 after 139 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: 1 generation back to K090159 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090159: Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families, Incisive Surgical, Inc. (2009) Summary page 1.

## Indications for use
Surgimatix PruxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subtuticular closure of skin with an approximate thickness of I to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation. The device is not indicated for use in shallow or very small incisions, and is not indicated far final closure of the terminal 2 cm of incisions.

Source page: https://510kreport.com/device/K132669
Methodology: https://510kreport.com/methodology