Medacta receives FDA clearance for kinematic alignment instrumentation for total knee replacement

Medacta International announced it received FDA clearance for the GMK sphere, a kinematic alignment instrumentation and surgical technique for total knee replacement, according to a company press release.

According to the release, the instrumentation and technique are components of the Medacta individualized kinematic alignment (MIKA) offering, which is based on the kinematic alignment surgical approach that has shown significant benefits for appropriate knee arthroplasty patients. Medacta worked with orthopedic surgeon Stephen Howell, MD, on the development of the instrumentation.

Through the Medacta Orthopaedic Research and Education (MORE) Institute, Medacta will offer educational tools to change the accessibility of kinematic alignment. In addition to traditional metal instrumentation, MyKnee, a planning protocol for patient-specific instruments, will allow surgeons to ease into kinematic alignment through the use of surgeon-specific parameters.

“Medacta is committed to cutting-edge medicine and new surgical approaches that advance orthopedics, focusing on personalized medicine and improving the overall patient experience,” Francesco Siccardi, CEO of Medacta International, said in the release. “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 MORE Institute, as we look to bring this promising innovation – and all of its patient benefits – into the mainstream.”

The GMK sphere will be displayed at the American Association of Hip and Knee Surgeons Annual Meeting in Dallas.

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