947351a2-9805-455c-9e8f-4ae19e49fcefUpdatePublished42023-09-072015-08-292018-03-25Not in Commercial Distribution03596010562425PrimaryGS1EMPERION7129182771291827045483575Smith & Nephew, Inc.1EMPERION SLEEVE 21 LG CONE3 SPOUT SLOTTEDfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)238-7538GUDID@SMITH-NEPHEW.COMK05242600033581Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.trueActiveMEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphatetruefalse