06dcb779-19fd-41c0-8d6d-198abebefefeUpdatePublished32018-07-062015-09-16In Commercial DistributionM209103010PrimaryHIBCCUNI LM/RL MD10301618749857BIOPRO, INC.1falsefalsefalsefalsefalsetruetruetruetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK89004400034209Coated unicondylar knee femur prosthesisA sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation may be performed with or without bone cement.trueActiveHRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymertruefalse