Medacta International has secured clearance from the US Food and Drug Administration (FDA) for GMK Sphere, Kinematic Alignment instrumentation and surgical technique for total knee replacement (TKR).
The manual instrumentation and technique are parts 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 showed significant benefits for appropriate knee arthroplasty patients.
Medacta partnered with orthopedic surgeon Stephen Howell, a pioneer in kinematically aligned total knee replacement at Adventist Health Lodi Memorial in Lodi, California, for the development of the instrumentation.
The company stated that the kinematic alignment technique intends restore normal knee function by resurfacing the femur and tibial articular surfaces to those of the normal or pre-arthritic state.
The approach is intended to achieve optimal patient satisfaction and function, while minimize damage to the surrounding tissues and ligaments.
Studies and patient outcomes are starting to create awareness that kinematic alignment could prove to be an appropriate option for knee arthroplasty patients.
Kinematic Alignment will add to Medacta’s efforts in developing personalized solutions and to the GMK Sphere Total Knee System, a medially stabilized design that takes full advantage of the kinematic approach due to its intrinsic design features.
Howell said: “Kinematic alignment will play a significant role in the future of total knee replacement and is an extremely effective alignment option for most patients. This approach, which co-aligns the axes of the components with the three kinematic axes of the native knee, offers many benefits to knee replacement candidates.
“The kinematic alignment technique has potential for faster recovery, quicker return to normal activities, overall, more comfort with the implant itself, and high long-term implant survival.”
Medacta International CEO Francesco Siccardi said: “Medacta is committed to cutting-edge medicine and new surgical approaches that advance orthopedics, focusing on personalized medicine and improving the overall patient experience.
“Our success in this area stems from our steadfast dedication to surgeon education, particularly around new strategies like Kinematic Alignment. Similar to how we disseminated the anterior approach to hip surgery through our AMIS education program, the MIKA procedure will be a new discipline within our M.O.R.E. Institute, as we look to bring this promising innovation – and all of its patient benefits – into the mainstream.”