8379461e-df40-4854-b22c-8cde6d1f6902NewPublished12022-02-012022-01-24In Commercial Distribution00840286830331PrimaryGS1CKS Plus2596-0-63362596-0-6336085976260Shalby Advanced Technologies, Inc.16mm Tibial BP, Stemmed, Peg, Full Wrap, R, 6, 3° SlopetruefalsefalsefalsetruetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(916)355-7100155khansen@consensusortho.com32832Uncoated 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