ee620b84-a7d6-4f81-bf62-d687dc4a5966UpdatePublished52024-03-152015-09-17In Commercial Distribution00814193021908PrimaryGS1B-P TOTAL KNEE SYSTEM04-32-082504-32-0825803488357ENDOTEC, INC.1B-P KNEE TIBIA PLATFORM COMPONENT, W/BIOCOAT, W/ULTRACOAT, TYPE 3, SIZE 5.5 falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK01270200033664Cruciate-retaining total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.trueActiveJWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDevice Size Text, specifySIZE 5.5, TYPE 3Storage Environment TemperatureHandling Environment Temperaturetruefalse