# K013059: Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)

- Pathway: 510(k) (Traditional)
- Applicant: Stony Brook Surgical Innovations, Inc.
- Decided: Oct 22, 2001 after 41 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: 1 generation back to K931271 (1994). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.

## Most influential descendants
- K023411: Steelex Sternum Set (2002), 4 descendants of its own
- K110039: Biomet Sports Medicine Sternal Closure System (2011), 1 descendant of its own
- K063603: Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (2007), 1 descendant of its own
- K032468: Suturtek Fastclose Sternum Closure Device (2003), 1 descendant of its own
- K191030: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (2020), 0 descendants of its own

## Indications for use
The Stony Brook Surgical Innovations’ (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the stemum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.

Source page: https://510kreport.com/device/K013059
Methodology: https://510kreport.com/methodology