# K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis

- Pathway: 510(k) (Traditional)
- Applicant: Sic Brevetti S.R.L.
- Decided: Dec 8, 2009 after 267 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K875156 (1988). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063017: Aesculap Sternumfix Sternal Closure System, Aesculap, Inc. (2006) Summary page 1.
- K063009: Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes), Praesidia S.R.L. (2006) Summary page 1.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K063603: Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17, Suturtek Incorporated (2007) Summary page 1.

## Indications for use
The Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.

Source page: https://510kreport.com/device/K090686
Methodology: https://510kreport.com/methodology