# K031508: Synthes (Usa) Sternal Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 30, 2003 after 16 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
No predicates in its family tree.
57 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Cerclage Wire (Pre-76): named in the summary without a submission number

## Most influential descendants
- K122293: Pioneer Sternal Cable Plate System (2012), 46 descendants of its own
- K133785: Tritium Sternal Cable Plate System (2014), 45 descendants of its own
- K150581: Tritium Sternal Cable Plate System (2015), 44 descendants of its own
- K161876: Tritium® Sternal Cable Plate System (2016), 43 descendants of its own
- K193468: Tritium Sternal Cable Plate System (2020), 40 descendants of its own

## Indications for use
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

Source page: https://510kreport.com/device/K031508
Methodology: https://510kreport.com/methodology