During the limited-release phase, a group of European and American expert surgeons implanted more than 400 GMK Sphere CR, reporting positive short-term performance. GMK Sphere CR was part of the M.O.R.E. Excellence Clinical Program, a structured process that defines the steps and milestones required for a Medacta product to reach full release on the market. This new option was tested over one year prior to launch through an intensive evaluation program that included computational and in vitro trials.
The CR insert is a new soft tissue preserving option for GMK Sphere
that accommodates the posterior cruciate ligament for a less invasive surgery. GMK Sphere is a medially stabilized implant with a medial ball-in-socket that ensures the stability of the medial compartment, and a flat lateral compartment that allows lateral mobility for patient-specific kinematics. The GMK Sphere CR Insert combines all the advantages of a medial pivot design in terms of kinematics, with a soft tissue preserving design, created to help enhance personalized patient outcomes.