MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate

Tuesday, September 24, 2019

Today MiRus announced recent FDA 510(k) clearance of the CYGNUS™ Anterior Cervical Plate System, the narrowest and thinnest cervical plate on the market. The unique I-beam design and metal alloy used in the plate allows for a dramatically smaller footprint without sacrificing performance. The CYGNUS™ Anterior Cervical Plate with its narrower profile will lead to less retraction and anterior vertebral body preparation resulting in shorter operative times and minimizing risk of complications such as dysphagia and dysphonia in patients undergoing anterior cervical fusion.

“The CYGNUS plate is remarkably thin and strong making it easy to implant with unparalleled graft visualization,”  stated Brian Scholl, MD, orthopaedic surgeon at The Orthopaedic Center, Huntsville, Alabama. “It truly represents a leap forward in implant design and metals technology.”

Dmitri Sofianos, MD, orthopaedic surgeon at Chatham Orthopaedic Associates, Savannah, GA commented, “The CYGNUS plate from MiRus is unique in almost every way. The new molybdenum alloy has allowed for a completely innovative and remarkably thin yet sturdy I-beam construction design that will not only reduce surgical implant time but improve patient outcomes.

“The approval of the CYGNUS Anterior Cervical Plate System is yet another major accomplishment as we strive to develop products that are best in class with resolve to improve patient outcomes and provide surgeons with premium products. I am enthusiastic to introduce a world class product into the ACDF marketplace that is well established and lacks innovative products such as the CYGNUS Anterior Cervical Plate,” remarked Wayne Gray, Senior Director R&D, Implant Systems.

MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate
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