21 Dec FDA 510(k) clearance for the TOMCAT™
Knoxville, Tenn. – December 21, 2015 – As 2015 comes to a close, ChoiceSpine is ending the year with a significant addition to their spinal implant product portfolio. The Knoxville-based spinal implant company announced today that it has received FDA 510(k) clearance for the TOMCAT™ stand-alone cervical device. This new device molds the benefits and functionality of two other ChoiceSpine products, STEALTH™ and FALCON™, into one while it expands innovation as one of the first stand-alone cervical devices that 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,” said 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 allows surgeons to address adjacent problems, like adjacent level disc disease. In addition, the adaptability of the device lends itself to a variety of unique specific surgeon preferences.
TOMCAT™ is one of the industry’s first stand-alone devices made with PEEK-OPTIMA HA Enhanced. Hydroxyapatite (HA) has a chemical and crystal structure similar to that found in bone. This new material allows for early bone apposition and superior bone quality formation compared to PEEK-OPTIMA.
“Like all of our systems and devices, TOMCAT™ was developed with the most innovative products available and an overall goal of making the surgeon’s job simpler and providing more peace of mind for the patients,” said ChoiceSpine co-principal Marty Altshuler.
“We’ve had an extremely busy and exciting year as we continue to grow and expand our product portfolio and look forward to what’s ahead in 2016,” added Altshuler.
For more information about ChoiceSpine, please visit www.choicespine.net.
ChoiceSpine is a privately held spinal implant company located in Knoxville, Tenn., and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to the market.