# K063017: Aesculap Sternumfix Sternal Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 27, 2006 after 86 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: 2 generations back to K923705 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K040864: Craniofix and CRANIOFIX2 Titanium Clamp System, Aesculap (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K011094: Synthes Sternal Fixation System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

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

## Indications for use
The Aesculap SternumFix Sternal Closure System is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

Source page: https://510kreport.com/device/K063017
Methodology: https://510kreport.com/methodology