c94e8e6b-e8ad-458f-b972-0bfbed4da6f6UpdatePublished112020-10-092017-08-07In Commercial Distribution00888912078818PrimaryGS1DJO SURGICAL425-98-009154074504Encore Medical, L.P.1Linear, STD, Reduced Neck, Sz 9, W/P2 CoatingfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety InformationfalsefalseK12024100033581Coated 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.trueActiveLZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncementedtruefalse