# K093772: Synthes Sternal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Mar 29, 2010 after 111 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.
94 later devices descend from it; 6 cite it directly.
0 of 95 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 System: named in the summary without a submission number
- (no number) Synthes Sterile Sternal Fixation System: named in the summary without a submission number
- (no number) Ethicon Stainless Steel Suture Wire: named in the summary without a submission number

## Most influential descendants
- K110789: Synthes Sternal Zipfix System (2011), 85 descendants of its own
- K111908: Biomet Microfixation Sternal Closure System (2011), 78 descendants of its own
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K151019: SternaLock® 360 Sternal Closure System (2015), 43 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. Contraindications The Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

Source page: https://510kreport.com/device/K093772
Methodology: https://510kreport.com/methodology