# K232986: VariTrax Sternal CircumFixation System

- Pathway: 510(k) (Traditional)
- Applicant: Circumfix Solutions, Inc.
- Decided: Jan 30, 2024 after 130 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
Longest line of descent: 10 generations back to K761228 (1976). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110789: Synthes Sternal Zipfix System, Synthes (Usa) (2011) Summary page 4.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 4.
- K151983: KLS Martin LSS Plating System, KLS Martin L.P. (2016) Summary page 4.

## Indications for use
The VariTrax Sternal CircumFixation system is indicated for 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/K232986
Methodology: https://510kreport.com/methodology