# K112689: Synthes Sternal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Synthes, Inc.
- Decided: Oct 26, 2011 after 41 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K093772 (2010). 1 ancestor in all.
31 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093772: Synthes Sternal Fixation System, Synthes (2010) Summary page 1.

## Most influential descendants
- K133616: Matrixrib Fixation System (2014), 26 descendants of its own
- K142823: Biomet Microfixation Thoracic Fixation System (2015), 23 descendants of its own
- K151173: Biomet Microfixation RibFix Blu Thoracic Fixation System (2015), 13 descendants of its own
- K152253: Biomet Microfixation RibFix Blu Thoracic Fixation System (2016), 11 descendants of its own
- K153482: KLS Martin Thoracic Plating System (2016), 9 descendants of its own

## Indications for use
The Synthes Sternal Fixation 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. The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated 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/K112689
Methodology: https://510kreport.com/methodology