ChoiceSpine Tomcat receives 510(k) clearance


ChoiceSpine has received  US Food and Drug Administration (FDA) 510(k) clearance for Tomcat, a stand-alone cervical device. This new device is designed to combine the functionality of two other ChoiceSpine products; Stealth and Falcon. It also uses PEEK-Optima HA Enhanced.

“The modular functionality and adaptable design of Tomcat provides surgeons with one device that can be used across a range of different procedural styles,” says ChoiceSpine co-principal Rick Henson. “To put it simply, this device provides one solution for multiple problems.”

The Tomcat is available in two versions, including a hybrid option. The hybrid version is designed to allow surgeons to address adjacent problems, such as adjacent level disc disease. In addition, the device is intended to adapt to a variety of unique specific surgical preferences.

According to ChoiceSpine, Tomcat is one of the industry’s first stand-alone devices made with PEEK-Optima HA Enhanced. The use of hydroxyapatite should allow for early bone apposition and superior bone quality formation compared to PEEK-Optima.