SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene® Surface Technology

IndustryPRwire -- SeaSpine announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its NanoMetalene® surface technology with amended indications.

NanoMetalene describes a surface technology for interbody devices that incorporates a submicron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process. NanoMetalene is designed to provide a molecularly bonded layer of bone-friendly titanium on the entire surface area of the implant, including endplates and throughout graft apertures, 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 previously has been applied. SeaSpine intends to incorporate NanoMetalene with additional implant systems over the next year.

Keith C. Valentine, President and Chief Executive Officer Commented “Our innovative NanoMetalene surface technology continues to be a key differentiator in the marketplace, 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.”

Mike Hall, Senior Director, Marketing Commented “SeaSpine’s commitment to advancing the development of differentiated surface materials with clinically relevant design features is highlighted by the recent introductions of Reef Topography™ and WaveForm™ 3D-printed technology, The success of NanoMetalene, with more than 35,000 devices implanted to date, demonstrates that our focus on science and data allows us to deliver implants deliberately designed to facilitate the best fusion results for patients.”

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