8ddde6c4-961c-4ede-a127-3c36b22c8416UpdatePublished22019-12-112019-04-17In Commercial Distribution04026575372829PrimaryGS1Gemini SL318-372/01318-372/01315675488WALDEMAR LINK GmbH & Co. KG1Tibia Component - fixed bearing, posterior StabilitruefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK18287200032832Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial 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 an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.trueActiveJWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMERtruefalse