Pinnacle Spine Group Files Application with FDA for 510(k) Clearance to Market their InFill® Lateral Fusion System with PEEK-OPTIMA™ HA Enhanced Polymer
Pinnacle Spine Group Seeking Clearance to Market its InFill® Lateral Fusion System with Invibio Biomaterial Solutions´ PEEK-OPTIMA™ HA Enhanced Polymer.” Copyright Pinnacle Spine Group
Dallas, Texas and Thornton Cleveleys, UK - Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systemswith PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions (Invibio).
Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. Invibio’s PEEK-OPTIMA HA Enhanced polymer is an implantable biomaterial grade that combines two clinically proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA and Hydroxyapatite (HA), a well-known osteoconductive material. PEEK-OPTIMA HA Enhanced encourages bone on-growth on all surfaces of a device while providing the strength, versatility and performance advantages of its proven predecessor, PEEK-OPTIMA Natural.
“We are excited about the possibility of combining the proven clinical benefits of Invibio’s PEEK-OPTIMA HA Enhanced with the benefits of Pinnacle Spine’s patented InFill technology,” said Zach Sowell, President of Pinnacle Spine Group. “Once cleared we believe the combination of these two technologies will provide surgeons with an ideal solution for improved outcomes in lumbar fusion, one of the more challenging approaches to achieve successful fusion.”
“Pinnacle Spine Group and Invibio share a passion for trying to improve the effectiveness of bone growth in the graft space,” said John Devine Medical Business Director, Invibio Biomaterial Solutions. “The combination of Pinnacle’s technology with our own pioneering materials feels like an obvious collaboration.”
Invibio´s PEEK-OPTIMA HA Enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).
Pinnacle Spine Group was recently granted a new patent related to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies. In addition, Pinnacle was recently awarded a new patent related to the architecture of the lateral implant. These latest patents follow the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.
Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.
About Pinnacle Spine Group, LLC
Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-510(k) cleared InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.
About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide.
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.
Mr. Zach Sowell, President
Pinnacle Spine Group, LLC
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