Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

PrinterPrezz Granted FDA Clearance for New 3D-Printed Spine Devices

PrinterPrezz received FDA 510(k) clearance for the PrinterPrezz GAIA™ Lumbar Interbody Fusion Device (LIFD) family of spine implants. The first systems announced today under the GAIA platform include the Astraeus ALIF, Themis TPLIF and Prometheus PLIF systems. Market introduction plans are underway.

The Astraeus, Themis and Prometheus systems are manufactured in titanium (Ti6Al4V-ELI) using Laser Powder Bed Fusion. Some of the designs leverage technologies jointly developed at the San Francisco VA Health Center and University of California (UCSF). This licensing deal was negotiated with UCSF Innovation Ventures’ Office of Technology Management, which leads licensing and business development efforts on behalf of the university in collaboration with the VA.

“The products announced today represent our cumulative learnings in medical device design, additive manufacturing processes, non-active implantable medical device (NAIMD) testing, cleaning, packaging & sterilization, and quality management,” said Shri Shetty, CEO of PrinterPrezz. “What makes GAIA™ a true reference platform, and PrinterPrezz a true medical device foundry, is that our customers have access to the array of technologies developed and validated during the GAIA™ program for their own product lines. Experienced customers benefit from our 3D print and design optimizations that help reduce manufacturing costs, while small, and mid-size customers may find benefit leveraging our FDA documentation.”

Dr. Alan Dang, Chief Medical Officer of PrinterPrezz, said, “GAIA™ represents a core technology platform that showcases both PrinterPrezz’s existing technology leadership in additive manufacturing, and serves as the foundation for PrinterPrezz’s ongoing research and development in support of our customers.”