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ChoiceSpine receives FDA clearance for stand-alone cervical device

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ChoiceSpine, a Knoxville-based spinal implant company, recently announced it has received FDA 510(k) clearance for its TOMCAT stand-alone cervical device.

The new device molds the functionality of two other ChoiceSpine products, the STEALTH and FALCON, and is reportedly one of the first stand-alone cervical devices that uses PEEK-OPTIMA Hydroxyapatite (HA)-enhanced materials, according the press release.

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

The TOMCAT is available in a hybrid version, which allows surgeons to address adjacent problems, like adjacent level disc disease. The new device is made with PEEK-OPTIMA HA-enhanced materials. This new material allows for early bone apposition and superior bone quality formation compared to PEEK-OPTIMA, according to the press release.

Reference:

www.choicespine.net