FDA Clears PorOsteon’s Phusion Metal™ Nitinol-Based Cervical Cage

Specialist in Nitinol-based technologies for the treatment of musculoskeletal indications, PorOsteon Inc., has received U.S. FDA 510(k) clearance for its new Phusion Metal™ Cervical Cage. The aim of the concept is to maximize bone growth through a fully interconnected porous structure, matching the modulus of living cancellous bone.

Background

The Phusion Metal Cervical Cage is targeting the limitations of conventional spinal fusion devices, including excessive stiffness, cage migration, minimal bone apposition and poor incorporation. It is the first of a family of surgical devices taking advantage of the unique properties of Phusion Metal.

Phusion Metal’s unique and irregular porous morphology delivers the benefits of structural strength, potential for bone in-growth, bone through-growth, and relative low cost of manufacturing. The PorOsteon claims its material 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.

This clearance sees it indicated for intervertebral body fusion of the spine in skeletally mature patients. The Cervical Cage is intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Company comments

Dr. Gary Fanton, orthopedic surgeon at Stanford University and co-founder of PorOsteon, stated: “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. 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.”

“The medical applications for Phusion MetalTM go well beyond spinal fusion,” added Bob Zider, co-founder of both PorOsteon and Nitinol Devices and Components (NDC). “This clearance is reminiscent of the time when we first developed and introduced Nitinol cardiovascular stents at NDC. Those devices changed that market dramatically. We believe we can drive similar change to the spinal fusion market with the introduction of the Phusion MetalTM Cervical Cage, as well as through the other products in development at PorOsteon including hip and knee applications, upper and lower extremities, small bones, SI joint fusion, along with craniomaxillofacial and dental implants.”

 

Source: PR Newswire

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