FDA clearance for mineralised collagen scaffold and cervical cage
The US Food and Drug Administration (FDA) has granted 510(k) clearance, or pre-market notification, for a next generation cervical cage and mineralised collagen scaffold (MCS) bone graft developed by BioStructures LLC.
Silhouette represents a new class of synthetic biomaterials designed to improve intra-operative handling and biologic responsiveness at the defect site, and comprises a bi-phasic mineral component suspended within a woven network of type I collagen fibres. The 90% porous matrix provides an interconnected structure optimised for the delivery of autogenic bone marrow aspirate and subsequent population of biologic factors essential to the healing process. Silhouette’s composition and structural properties deliver a bone graft that is tailored to support bone bonding and sustained remodelling as the healing process occurs.
Russell Cook, CEO of BioStructures, a privately held orthobiologics company, said: “We founded BioStructures with the goal to develop and commercialise proprietary first-in-class products in the bioactive, polymer, collagen and cellular bone graft spaces. The Silhouette clearance represents the third step in our attainment of that goal. We will continue to develop our pipeline of products in a continued effort to offer a unique breadth of products.”
Meanwhile, a new cervical cage, designed to maximise bone growth through a fully interconnected porous structure that matches the modulus of living cancellous bone, has also received pre-market clearance from the FDA.
The Phusion Metal Cervical Cage is composed of a proprietary porous material developed to promote bone fusion and address important limitations of conventional spinal fusion devices, such as excessive stiffness, cage migration, minimal bone apposition and poor incorporation.
Phusion Metal’s irregular porous morphology delivers the benefits of structural strength, potential for bone in-growth, bone through-growth, and a relatively low cost of manufacturing. It 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.
Gary Fanton, orthopaedic surgeon at Stanford University and co-founder of manufacturer PorOsteon, stated: “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 with 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 Phusion Metal Cervical Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. 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.
Source: PorOsteon Inc.