PorOsteon has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Phusion Metal Cervical Cage, developed to maximize bone growth through a fully interconnected porous structure and matching the modulus of living cancellous bone.
The device has been designed to address limitations of conventional spinal fusion devices, including excessive stiffness, cage migration, minimal bone apposition and poor incorporation.
PorOsteon co-founder and Stanford University orthopedic surgeon Dr Gary Fanton 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 realizing 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."
The device is indicated for intervertebral body fusion of the spine in skeletally mature patients, and is intended for use at one level in the cervical spine, from C3 to C7, to treat cervical disc disease.
Phusion Metal Cervical Cage is said to be used in patients who have had six weeks of non-operative treatment.
It is intended to be implanted through an open and anterior approach, and has to be used with autogenous bone and supplemental fixation such as an anterior plating system.
PorOsteon develops and markets Nitinol-based Phusion Metal for a wide range of musculoskeletal indications.