Medacta Gains FDA Clearance for Kinematic Knee Alignment

By Julie A. Vetalice

Medacta International was granted FDA 510(k) clearance to market the GMK® Sphere – Kinematic Alignment surgical technique and technique-specific instruments for total knee arthroplasty (TKA).

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.

Source: Medacta International

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory