ChoiceSpine Granted FDA Clearance for 3D Printed HAWKEYE Ti VBR

By Julie A. Vetalice

Image courtesy of ChoiceSpine LP

ChoiceSpine received FDA 510(k) clearance to market the HAWKEYE Ti 3D-printed titanium vertebral body replacement.

HAWKEYE Ti is the company's first 3D-printed device and offers the same implant portfolio as the original PEEK version, which launched in 2012 and featured implants in 21 heights and 2 footprints. The portfolio comprises small and large footprints of 10mm to 50mm in height with 0° or 6° lordosis. HAWKEYE is to be used with autograft and/or allograft; earlier this year, ChoiceSpine launched its own line of orthobiologics.

Sources: ChoiceSpine LP; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory