# K082828: Suturtek 360 Degree Sternal Closure Device

- Pathway: 510(k) (Special)
- Applicant: Suturtek Incorporated
- Decided: Oct 14, 2008 after 19 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: 4 generations back to K931271 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032468: Suturtek Fastclose Sternum Closure Device, Suturtek Incorporated (2003) Summary page 1.

## Indications for use
The Suturtek 3600 Sternal 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 needle stick injuries.

Source page: https://510kreport.com/device/K082828
Methodology: https://510kreport.com/methodology