The first U.S. procedure has occurred using the Mecta-C Stand Alone platform for anterior cervical discectomy and fusion procedures following its FDA 510(k) clearance 1Q20. Mecta-C Stand Alone has also obtained approval under the CE Mark in Australia.
Mecta-C Stand Alone requires no additional fixation and features a modular design that allows intraoperative selection from four plating options to treat various patient needs and anatomies. The devices are offered in TiPEEK plasma-sprayed titanium coating for stability and resistance to migration.
Mecta-C Stand Alone will launch shortly in Australia and several European countries.