PorOsteon announces FDA clearance of the Phusion Metal cervical cage

179

PorOsteon has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its new Phusion Metal cervical cage, designed to maximise bone growth through a fully interconnected porous structure and matching the modulus of living cancellous bone. 

The Phusion Metal cervical cage is designed to address important limitations of conventional spinal fusion devices, including excessive stiffness, cage migration, minimal bone apposition and poor incorporation. The cage is the first of a family of surgical devices employing Phusion Metal.

Phusion Metal’s irregular porous morphology delivers the benefits of structural strength, potential for bone in-growth, bone through-growth, and relative low cost of manufacturing. Phusion Metal addresses the biomechanical limitations of other synthetic materials by closely matching the elastic modulus and irregular pore structure of natural cancellous bone, while providing structural integrity afforded by a fully porous metal and biocompatibility inherent to Nitinol.

Gary Fanton, orthopaedic surgeon at Stanford University and co-founder of PorOsteon, said: “This bone fusion material is designed to not only contain autogenous bone graft, but to actually integrate into the surgically-corrected spinal column. Clinicians are realising the immense importance of the materials used for bone fixation and fusion. Some of these materials are essentially solid plastic, metal, or ceramic that subsides, migrates, and actually displaces surface area necessary for optimal bone in-growth. Instead, our testing has demonstrated that fusion devices must achieve an engineered balance among porosity, strength, and elastic modulus. Phusion Metal is the first implant material that addresses all three of these concerns effectively, representing a great improvement compared to conventional and surface enhanced interbody cage materials. Now implants can be designed with a material that is both surgeon and bone friendly. There will be no additional learning curve to use these implants, and they will address our primary concern in spinal surgery, obtaining a rapid and robust fusion.”