Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the GMK® Sphere – Kinematic Alignment instrumentation and surgical technique for total knee replacement (TKR). The manual instrumentation and technique are components of the new Medacta Individualized Kinematic Alignment (MIKA) offering, which is based on the kinematic alignment surgical approach, an alternative to traditional mechanical alignment for TKR that has demonstrated significant benefits for appropriate knee arthroplasty patients. Medacta collaborated on the development of the instrumentation with renowned orthopedic surgeon Dr. Stephen Howell, a pioneer in kinematically aligned total knee replacement at Adventist Health Lodi Memorial (Lodi, California).
