# K180582: Sternal Cable System

- Pathway: 510(k) (Traditional)
- Applicant: A & E Medical Corporation
- Decided: May 31, 2018 after 87 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: 1 generation back to K935481 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935481: Sponger Cable System, Modification, Pioneer Surgical Technology (1994) Summary page 4.

## Most influential descendants
- K193479: Sternal Cable System (2020), 0 descendants of its own

## Indications for use
Cardiovascular surgery - closure of the sternum following sternotomy.

Source page: https://510kreport.com/device/K180582
Methodology: https://510kreport.com/methodology