FDA approves Medacta’s two new kinematic alignment options for knee replacement surgery

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).

"Kinematic alignment will play a significant role in the future of total knee replacement and is an extremely effective alignment option for most patients," said Dr. Howell, who has been practicing a version of the technique for over a decade. "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. The use of the caliper technique and the recording of intraoperative checks restores the native joint lines, limb alignment, compartment forces, and laxities of the pre-arthritic knee with high reproducibility with few ligament releases. In working with Medacta, we've put together a program that builds on the benefits of this surgical strategy while opening it up to even more surgeons looking to learn and practice the approach."

The kinematic alignment technique aims to restore normal knee function by resurfacing the femur and tibial articular surfaces to those of the normal or pre-arthritic state. This approach is aimed at achieving optimal patient satisfaction and function, while minimizing damage to the surrounding tissues and ligaments. Studies and patient outcomes are starting to create awareness that kinematic alignment may offer benefits for appropriate knee arthroplasty patients.

Kinematic Alignment will be an addition to Medacta's efforts towards personalized solutions and to the GMK Sphere Total Knee System, a medially stabilized design that facilitates taking full advantage of the kinematic approach due to its intrinsic design features.

Medacta looks to change the accessibility of kinematic alignment by providing dedicated educational tools through the M.O.R.E. Institute as well as new instrumentation. In addition to traditional metal instrumentation, a dedicated planning protocol for patient-specific instruments (MyKnee®) will allow surgeons to ease into the technique through the use of surgeon-specified 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," said Francesco Siccardi, Chief Executive Officer of Medacta International. "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."

This innovation will be on display at the 2018 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting this week in Dallas and will launch more broadly in Spring 2019. Visit Medacta at Booth #215 onsite at AAHKS to see the new GMK Sphere - Kinematic Alignment instrumentation and explore the company's full portfolio of orthopedic technologies.

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