1154b364-a371-42cf-b0ea-a0f19e18ea1aUpdatePublished42019-12-112015-10-30In Commercial Distribution10885862003270PrimaryGS1Optetrak Logic02-012-41-506002-012-41-5060157565946Exactech, Inc.1falsefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK93361000032832Uncoated 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/PolymerDevice Size Text, specifySize 5F/6Ttruefalse