Device Information

Indications

The VariTrax Sternal CircumFixation System is indicated for the primary or secondary closure or repair of the sternum following sternotomy or fracture. It stabilizes the sternum and promotes fusion.  

Intended Use

The device is intended for individuals requiring sternal closure after sternotomy or sternal fracture. It stabilizes the sternum and aids in healing. The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate.  They are single-use devices provided in a sterile kit.  The VariTrax bands are placed in a peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum. The device should only be used by healthcare professionals trained in surgical procedures.

Availability

• Prescription use only (21 CFR 801 Subpart D)

Contraindications

No specific contraindications were noted in the 510k summary.

Limitations

The device is only suitable for patients who require sternal stabilization post-sternotomy or fracture. Proper handling by medical professionals is crucial.

Study Results

Biocompatibility testing followed ISO 10993-1 standards. Performance tests (lateral distraction, longitudinal shear, static tensile band, four-point bend, and needle pull-out) demonstrated the device’s equivalence to predicate devices.

Regulatory Information

The device has been determined to be substantially equivalent to its predicate devices and does not raise new safety or effectiveness concerns.

Manufacturer Information

• Name: CircumFix Solutions, Inc.
• Address: 475 East South St, Suite 102, Collierville, TN 38017
• Contact: Ken Richardson, Chief Commercial Officer

Predicate Device Information

• Predicate Device Name: Synthes Sternal ZipFix System (K110789), Ethicon Stainless Steel Suture Wire (K946173), and KLS Martin LSS Plating System (K151983)
• Difference:  The subject and predicate device are identical in intended use and materials and equivalent in technological characteristics. The VariTrax system uses PEEK materials and an improved locking mechanism compared to the predicate device’s metallic design. Testing has demonstrated that the performance of the subject device is equivalent to that of the predicate. Thus, the differences in geometry versus the predicates do not raise different questions of safety and effectiveness. 

Implications

The VariTrax Sternal CircumFixation System offers a modern approach to sternal fixation with its PEEK materials. It ensures stability and encourages healing post-surgery. It enhances patient outcomes by reducing complications related to sternum instability.

References

1. VariTrax Sternal CircumFixation System. 510k Number: K232986. FDA Summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232986
2. https://circumfix.com/