589299ce-541b-4b9a-ab70-a82174ead325UpdatePublished32018-07-062016-12-14In Commercial Distribution08177570200450PrimaryGS1Paxeon Origin Coxa Vara Hip StemPR111-18-1104080437990PAXEON RECONSTRUCTION LLC1Origin Stem, Coxa Vara Size 11 falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK16115500033581Coated 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-PhosphateKWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymertruefalse