# K211613: Stern Fix Sternal Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Neos Surgery S.L
- Decided: Jan 19, 2022 after 238 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 K931271 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110789: Synthes Sternal Zipfix System, Synthes (Usa) (2011) Summary page 6.

## Most influential descendants
- K221795: STERN FIX Sternal Stabilization System (2022), 0 descendants of its own

## Indications for use
The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

Source page: https://510kreport.com/device/K211613
Methodology: https://510kreport.com/methodology