MAGEC rods Pre Clinical Testing

Question 1

How does an implant come to market?

Answer 1

Design (engineers with surgeons),
Pre clinical lab tests, awarded CE mark by notified body, no clinical test required often on the basis of substantial equivalence (510k in US), fitted by surgeons, post market surveillance

Question 2

What is more accurate to mimic human posture bipedal or quadrupedal?

Answer 2

Bipedal, however no animal models can currently model all constraints and weaknesses of human spine

Question 3

History of MAGEC rods

Answer 3

Designed by Ellipse Technologies. Received CE mark in 2009. 2011 first implant in UK. 2012 first clinical results. 2013 first UK clinical results. 27 feb 2014 first magec rod approved by FDA