SeaSpine received FDA 510(k) clearance to market its NanoMetalene® surface technology with amended indications.
NanoMetalene surface technology for interbody devices incorporates a submicron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process. It provides a molecularly bonded layer of bone-friendly titanium on the entire implant surface area while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for postoperative imaging.
The new 510(k) clearance allows SeaSpine to describe NanoMetalene surface technology as “providing a microscopic roughened surface with nano-scale features” and amends indications for use across the 12 implant systems to which NanoMetalene has been applied. The technology has been used in over 25,000 implantations, to date. The company intends to incorporate NanoMetalene with additional implant systems throughout 2021.
“Our innovative NanoMetalene surface technology continues to be a key differentiator in the marketplace,” said Keith C. Valentine, President and Chief Executive Officer. “Foundational to our Fusion Engineered™ philosophy, these amended indications give us the opportunity to further educate surgeons about the benefits of NanoMetalene, including how its rough micro- and nano-scale topography is designed to encourage integration.”