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Medacta Gains FDA Clearance for Kinematic Knee Alignment -

Medacta received FDA 510(k) clearance to market the GMK® Sphere – Kinematic Alignment surgical technique and technique-specific instruments for total knee arthroplasty. The clearance adds an alternative alignment approach to TKA, allowing the procedure to be performed by either a manual, instrumented caliper technique or with patient-specific instrumentation. The MyKnee® dedicated planning protocol is designed to let surgeons ease into the technique through use of their own specified parameters; the patient-specific cutting block is used in pre-operative 3D planning based on CT or MRI images of the patient’s knee. (Medacta International, 11/1/18)