cff3826c-b59e-48ae-974c-a9b48f50b9acUpdatePublished32018-07-062015-09-24In Commercial Distribution07613327014013PrimaryGS1Total Elbow5003-15125003-1512058311945Howmedica Osteonics Corp.1Axle PinfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK98050200033702Uncoated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.trueActiveJDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTEDDevice Size Text, specifySize: SMtruefalse