e6690e25-1dc4-4e05-8f25-69692d89e121UpdatePublished22023-02-032021-08-17In Commercial Distribution07630345719003PrimaryGS1GMK Sphere Revision System02.19.PD08488227125Medacta International SA1GMK Sphere Revision Posterior Wedge S6 8mm falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK21166400048067Knee arthroplasty wedgeAn implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].trueActiveJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymertruefalse