
DEVELOPMENT MILESTONES:
Physicochemical test – done
Biocompatibility evaluation – done
Product development (prototype) – done
Wear testing using hip simulator – done.
Pilot clinical study in New Zealand – First stage of Marketing – done
CE Approval – done
Osteointegration in bone – done
FDA – Pre-submission – in process
Clinical studies in humans – in process
FDA 510k
CE (for other implants) approval
Marketing and sales