Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems
CARLSBAD, CA – June 4, 2018 – Astura Medical, a high growth, innovative spine technology company, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ALTA ACDF Interbody Spacers and HALF DOME Lumbar Interbody Spacers in PEEK-OPTIMAä HA Enhanced from Invibio Biomaterial Solutions.
Combining the clinically proven strength and versatility of PEEK-OPTIMA with Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, PEEK-OPTIMA HA Enhanced provides an innovative biomaterial for interbody fusion devices. HA is fully integrated, not coated, into the PEEK-OPTIMA matrix, ensuring it is present on all surfaces and throughout the implant.
“As surgeons continue to explore different surface technology options, we are excited about the addition of HA PEEK to our suite of interbody solutions,” said Thomas Purcell, Vice President of Astura Medical. “It once again reinforces Astura’s commitment to providing our surgeon partners with differentiated technology to enhance their ability to provide the best in patient care.”
ALTA and HALF DOME HA PEEK are now commercially available in multiple footprint, height, and lordotic options for ACDF, PLIF, and TLIF procedures. In addition to the launch of their HA PEEK lineup, Astura will be introducing its MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages later this year.
About Astura Medical
Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.
The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.
For more information, please visit www.asturamedical.com or find us on LinkedIn.
Media Contact:
Steve Haayen
Astura Medical
858.472.8825
