Cutting Edge Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its T-FIX 3DSI joint fusion system. The 3D-printed system is part of the company’s novel EVOL-SI fusion system portfolio, which is designed to treat dysfunctions of the sacroiliac joint.
The T-FIX 3DSI joint fusion system is cleared for multiple approaches: Lateral, S2 alar-iliac, open posterior bridging, and transgluteal lateral. The system’s trabecular technology promotes optimal osseointegration, positively impacting fusion and fixation, say the firm.
Randy Roof, Cutting Edge Spine’s president, CEO and founder, said: “FDA 510(k) clearance of this trabecular technology is the culmination of five years of internal development in the pursuit of higher quality patient care through solid science.
“Raising the bar in patient care continues to be our core objective, and the addition of the T-FIX 3DSI joint fusion system to our EVOL-SI fusion system delivers an incredibly novel and broad system for treating dysfunctions of the sacroiliac joint.”