MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System
WASHINGTON, Feb. 20, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful 510(k) clearance decision by the U.S. Food and Drug Administration (FDA) for Curiteva’s Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology.
Curiteva received FDA Clearance on the world’s first 3D printed, fully interconnected porous PEEK structure, utilizing an internally developed Fused Filament Fabrication novel process and printer. These proprietary printers create a unique porous scaffolding, resulting in a PEEK structure with superior biomechanical strength compared to traditional PEEK implants. This unique architecture and capability to print bone-like scaffolding structures, with the addition of the patented HAFUSE nano-texturing, creates a superior biological environment for bone in-growth throughout the entirety of the implant structure. Curiteva partnered with MCRA previously on Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023, which also received FDA clearance. MCRA’s Spine Regulatory team engaged with Curiteva for the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. The project utilized MCRA’s strategic regulatory expertise to navigate the FDA’s questions and testing requirements, resulting in FDA 510(k) clearance for the device.
Justin Eggleton, Vice President, Head of Musculoskeletal Regulatory Affairs at MCRA, said “MCRA is honored to have collaborated on the pioneering project of Curiteva’s Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology and the resulting FDA clearance. This innovative device combines the latest in 3D printing, biomaterial science, and engineering excellence that will offer improved surgical solutions for this patient population. MCRA’s dedication to advancing patient care through innovative solutions has found a remarkable embodiment in this project.”
“Working with MCRA as a strategic partner to advance our regulatory portfolio utilizing our transformative porous PEEK technology was critical in the rapid achievement of our recent FDA 510(k) clearance. Due to the collaborative efforts of the MCRA and Curiteva teams, the comprehensive 510(k) review process took less than 60 days from submission to clearance – a remarkable achievement. The professional acumen exhibited by the regulatory group at MCRA is a primary reason they continue to be a powerhouse in the industry,” commented Curiteva’s Chief Technology Officer and Founder, Eric Linder.
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.co
About Curiteva: Curiteva is a privately held technology and manufacturing company dedicated to advancing spine surgery and improving clinical outcomes by partnering with providers and suppliers to deliver innovative and intuitive implant systems to the market. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. For more information, please visit www.curiteva.com.
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com
SOURCE MCRA, LLC
