# K023411: Steelex Sternum Set

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 19, 2002 after 69 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: 2 generations back to K931271 (1994). 3 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.
- K013059: Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures), Stony Brook Surgical Innovations, Inc. (2001)
- K991073: Acier Sutures, Cardio Thoracic Systems (1999) Summary page 1.

## Most influential descendants
- 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
- K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis (2009), 0 descendants of its own
- K082828: Suturtek 360 Degree Sternal Closure Device (2008), 0 descendants of its own

## Indications for use
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.

Source page: https://510kreport.com/device/K023411
Methodology: https://510kreport.com/methodology