# K052683: Synthes (Usa) Sternal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Dec 5, 2005 after 68 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 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 Sternal Fixation Systems: named in the summary without a submission number

## Most influential descendants
- K101170: Acute Innovations Sternal Fixation System (2010), 10 descendants of its own
- K113318: Acute Innovations Modular Ribloc System (2012), 8 descendants of its own
- K141241: Matrixrib Endo Thoracoscopic Rib Plating System (2014), 5 descendants of its own
- K183317: AdvantageRib System (2019), 4 descendants of its own
- K203474: Biomet Microfixation RibFix Advantage System (2021), 3 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. CONTRAINDICATIONS The Synthes Titanium 2.4mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

Source page: https://510kreport.com/device/K052683
Methodology: https://510kreport.com/methodology