CTL Amedica has received official 510(k) clearance from the US Food and Drug Administration (FDA) to market its Navigation Instrument System. The system features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in precisely locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of pedicle screws.
CTL Amedica’s chief executive officer, Daniel Chon, said: “The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery. It is an innovative system of drivers, taps, awls, probes and drills that enables surgeons to navigate anatomic structures with insightful precision.
“This can make a tremendous difference for surgeons and their patients, ultimately reducing procedure times and improving outcomes. I’d like to thank everyone who provided support and feedback to help make this endeavour a reality.”
The system is compatible with CTL Amedica’s RAPHAEL pedicle screw system family, the PICASSO II MIS spinal system family and the TAURUS pedicle screw system family.