Promimic US customer Curiteva announces first FDA 510(k) clearance for their 3D-printed PEEK implant
Promimic and Curiteva have been working together to incorporate the Promimic surface technology with Curiteva’s new 3D-printed porous PEEK cervical implant for spinal fusion.
“We have a great partnership, and this clearance is the culmination of many hours of dedication and commitment to the project from our combined teams.? The contributions Promimic has made to this effort are all greatly valued and fundamental to our technology”, says Eric Linder, Co-Founder and Chief Technology Officer of Curiteva.
Huntsville, AL based technology company, Curiteva announces the first ever FDA 510(k) cleared 3D printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE?Technology.? The first-to-market combination of the HAFUSE?nanotechnology surface treatment and novel porous PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.
“We are pioneering 3D printing of porous PEEK implants with the bioactive surface from Promimic to revolutionize how engineered structures and implant biomaterials enhance healing and improve patient outcomes”, Curiteva Inventor and Vice President of Emerging Technology Todd Reith comments.
Curiteva is uniquely positioned to control the product development process of traditional implants and 3D printed devices from inception to commercialization and scale to meet market demand inside their 35,000 sq ft production facility in Huntsville, Alabama, USA. They plan for a commercial launch in key academic centers across the United States later this year.
“We are looking forward to supporting the upcoming commercial launch of this groundbreaking device, and to grow the partnership with Curiteva even further”, says Magnus Larsson Promimic CEO in a comment.
Magnus Larsson, CEO at Promimic
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Promimic is a growth company that develops and markets biomaterials for improved osseointegration to leading companies in the fields of dental and orthopedic implants. The main product HAnano Surface has been developed from cutting edge research at Chalmers University of Technology in Sweden. The technology is proven to improve osseointegration in over 30 scientific studies and with over 900,000 implants in clinical use. Promimic has offices in Mölndal, Sweden and Austin, Texas, USA. For more information visit www.promimic.com
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.