SAN RAMON, Calif., June 20, 2018 /PRNewswire/ — Tenon Medical, Inc., a manufacturer of minimally invasive instruments and implants for sacroiliac joint fusion surgery, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ Fixation System) specifically indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. The CAT SIJ Fixation System becomes the first patented single implant SIJ fusion system using a true posterior approach for minimal tissue disruption.
“With the FDA 510(k) clearance of the CAT SIJ Fixation System, Tenon now has the first patented single implant SIJ fusion system that allows surgeons to use either a navigated procedure or fluoroscopic imaging providing flexibility in access and visibility. The implant is designed to allow for bone graft materials to be loaded and delivered to the SIJ before and after implant placement to promote fusion of the SIJ,” said Tenon CEO Dr. Kal Mentak. “Our unique minimally invasive approach is designed to take less time and fewer surgical steps and represents a landmark innovation for SIJ fusion surgery benefiting patients, surgeons, facilities, and payers.”
In November 2016, Tenon Medical, Inc. was granted the first US patent covering a novel minimally invasive posterior approach fusion system to stabilize the SIJ. The company has since filed for additional compositions.
Tenon Medical, Inc. is a privately held company located in the San Francisco Bay Area.
For inquiries about the CAT SIJ Fixation System, please contact Kal Mentak, PhD at (925) 353-0533 or [email protected].
SOURCE Tenon Medical, Inc. http://tctig.com