Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems
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-OPTIMA™ 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.