FDA 510(k) clearance for cervical and lumbar HA PEEK interbody systems

ALTA PEEK HA anterior cervical discectomy and fusion interbody spacers (Astura Medical)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar interbody spacers in PEEK-OPTIMA Hydroxyapatite Enhanced (Invibio Biomaterial Solutions).

PEEK-OPTIMA HA Enhanced provides an innovative biomaterial for interbody fusion devices, a press release states, as it combines “the clinically proven strength and versatility of PEEK-OPTIMA with Hydroxyapatite, a well-known osteoconductive material that enhances bone apposition”. The hydroxyapatite is integrated into the PEEK-OPTIMA matrix, rather than coated, ensuring it is present on all surfaces, as well as 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,” says 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 anterior cervical discectomy and fusion (ACDF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF) procedures. In addition to the launch of their HA PEEK lineup, Astura will be introducing its minimally invasive percutaneous screw system and expandable posterior lumbar interbody cages later this year.


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