255fc06f-fcd8-44e4-ad55-d26357ef3591NewPublished12021-08-172021-08-09In Commercial Distribution07630345723819PrimaryGS1GMK Total Knee System02.12.KA53R488227125Medacta International SA1Anatomical Femoral Component SPHERIKA Cemented S3+RfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK21100400032831Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.trueActiveJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymertruefalse