CircumFix Solutions, Inc.

CircumFix Solutions manufactures the VariTrax Sternal CircumFixator System, a rigid sternal closure device for cardiothoracic surgery. The system provides innovative sternal stabilization following median sternotomy procedures. The VariTrax device is fabricated entirely from PEEK (VESTAKEEP® polymer), a biocompatible, radiolucent material that offers 3D stability and load distribution across the anterior table of the sternum. The system combines a deformable anatomically conforming plate with PEEK compression bands (cerclage) in a unibody construction, enabling surgeons to splint the entire sternum while distributing closure forces more broadly than traditional wire cerclage methods. The product line includes six sized sternal circumfixator sets (ranging from 130mm to 186mm), a template kit for intraoperative sizing, an instrument kit, and individual PEEK bands with curved blunt needles. All components are supplied as sterile kits. The VariTrax system has received FDA clearance and is designed for quick and easy application with simple removal. CircumFix targets cardiothoracic surgical centers and hospitals performing high-volume median sternotomy procedures (approximately 700,000 annually in the USA). The company provides comprehensive Instructions for Use (IFU) documentation, clinical support materials, and educational resources including video demonstration of surgical technique. Manufacturing and regulatory compliance align with medical device standards for surgical implants and instruments used in cardiac surgery.