T-FIX 3DSI Joint Fusion System Receives FDA 510(k) Clearance

Cutting Edge Spine (CES) announced the FDA 510(k) clearance of its proprietary sacroiliac T-FIX 3DSI Joint Fusion System.

The 3D-printed T-FIX 3DSI Joint Fusion System is part of the novel EVOL-SI Fusion System portfolio, which is designed to treat dysfunctions of the sacroiliac joint, and is cleared for multiple approaches: Lateral, S2Al (S2 Alar Iliac), Open Posterior Bridging and Transgluteal Lateral. The system’s trabecular technology promotes optimal osseointegration, positively impacting fusion and fixation.

“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,” said Randy Roof, President, CEO and Founder, CES. “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.”

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