PorOsteon Wins FDA Nod for Phusion Metal Cervical Cage
San Diego, Calif.-based PorOsteon has received FDA 510(k) clearance for its Phusion Metal Cervial Cage for the treatment of cervical disc disease. The cage is designed to maximize bone growth through a connected porous structure that mimics the elasticity of natural bone, the company said Friday.
PorOsteon said its device addresses the limitations of conventional spinal fusion devices such as excessive stiffness, cage migration, minimal bone merging and poor incorporation. The cage’s Phusion Metal addresses the biomechanical limitations of other materials by closely matching the pore structure and natural sponginess of bone, the company added.
Gary Fanton, co-founder of PorOsteon said clinicians are realizing the materials they use for bone fusion — such as solid plastic, metal and ceramic — actually can distort the surface area necessary for optimal bone in-growth. This device achieves a balance of porosity, strength, and elastic modulus, he added.
The company says it anticipates using the material in developing products for hip and knee replacements, upper and lower extremities, small bones and even dental implants. — Kellen Owings