Cutting Edge Spine (CES) announced the FDA 510(k) clearance of its proprietary SI Joint Fusion System, 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. The T-FIX 3DSI Joint Fusion System is FDA 510(k) cleared for multiple approaches: Lateral, S2Al (S2 Alar Iliac), Open Posterior Bridging and Transgluteal Lateral. The system’s trabecular technology is designed to promote 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 CES President, CEO & Founder, Randy Roof. “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.”
Cutting Edge Spine (CES) announced the FDA 510(k) clearance of its proprietary SI Joint Fusion System, 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. The T-FIX 3DSI Joint Fusion System is FDA...
Cutting Edge Spine (CES) announced the FDA 510(k) clearance of its proprietary SI Joint Fusion System, 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. The T-FIX 3DSI Joint Fusion System is FDA 510(k) cleared for multiple approaches: Lateral, S2Al (S2 Alar Iliac), Open Posterior Bridging and Transgluteal Lateral. The system’s trabecular technology is designed to promote 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 CES President, CEO & Founder, Randy Roof. “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.”
Copy to clipboard 
