4173a8bd-a26e-40ba-b646-7677029cc949UpdatePublished32018-07-062015-09-24In Commercial Distribution07613327047950PrimaryGS1Kinemax6476-3-1006476-3-100058311945Howmedica Osteonics Corp.1Tibial Full Block WedgefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK96495100033692Rotating hinged total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.trueActiveJWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMERDevice Size Text, specifySize: MEDDevice Size Text, specifyThickness: 10.0 Millimetertruefalse