MEDTECH Receives FDA Clearance for ROSA Spine Robot

By Julie A. Vetalice

MEDTECH received FDA 510(k) clearance to market the ROSA™ Spine robot assistive system for use in minimally invasive surgical procedures.

ROSA Spine received CE Mark approval in 3Q14, and its first commercial procedure occurred in 4Q14. The platform was previously cleared in the U.S. for brain surgery in 2012.


MEDTECH demonstrated the ROSA system at NASS 2015, among others with robotic and navigation systems on display:

  • Mazor launched the PRO (Predictable Renaissance Operation) line to address spinal deformity, trauma and lateral procedures
  • NuVasive showcased the Integrated Global Alignment (iGA™) procedural-based platform, including posterior fixation, anterior and posterior implants, updated neuromonitoring and computer-assisted surgical planning technology
  • Stryker introduced SpineMask™, a non-invasive patient tracker for use with SpineMap® 3D software to support minimally invasive approaches for spine surgery without an additional incision for navigation tracking

Product Labels: Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory