Medacta announced FDA 510(k) clearance and launch of the MySpine Midline Cortical Pedicle Screw Placement Guide (MySpine MC).
Using 3D-printed guides, MySpine MC technology guides the pedicle screw via established cortical bone trajectory (CBT). With CT-based pre-op planning of a more caudomedial entry point vs. traditional pedicle screw trajectories and a less extreme caudal-cranial angle than CBT, the technique avoids interference with cranial facet joints and accommodates larger screw diameters and lengths, with four points of cortical bone purchase for biomechanical fixation.
MySpine technology was first used in the U.S. in 2014 to address complex procedures. A low-profile version of the guide was introduced in 2016. MySpine MC and this multi-cortical approach have been used in >100 spinal surgeries to date in Australia, Asia and Europe.
Sources: Medacta International; ORTHOWORLD Inc.