# K032468: Suturtek Fastclose Sternum Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Suturtek Incorporated
- Decided: Sep 23, 2003 after 43 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931271 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011105: Suturtek Fastclose Fascia Closure Device, Qrc Consulting (2001)
- K030227: Suturtek Fastclose Suturing Device, Suturtek Incorporated (2003)
- K023411: Steelex Sternum Set, Aesculap, Inc. (2002)

## Most influential descendants
- K082828: Suturtek 360 Degree Sternal Closure Device (2008), 0 descendants of its own

## Indications for use
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.

Source page: https://510kreport.com/device/K032468
Methodology: https://510kreport.com/methodology