# K081700: Synthes (Usa) Sternal Fixation System - Line Extension

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Jul 17, 2008 after 30 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 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 (USA) Sternal Fixation System: named in the summary without a submission number
- (no number) Synthes (USA) Sterile Sternal Fixation System: named in the summary without a submission number

## 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 (USA) 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.

Source page: https://510kreport.com/device/K081700
Methodology: https://510kreport.com/methodology