208d2692-4f5f-43c8-b338-0d00c8cfc7c3UpdatePublished32018-07-062015-09-24In Commercial Distribution07613327137613PrimaryGS1SOLAR5005-013L5005-013L058311945Howmedica Osteonics Corp.1Elbow Humeral ComponentfalsefalsefalsetruefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK98050200033174Coated 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 coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.trueActiveJDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTEDDevice Size Text, specifySide: LEFTDevice Size Text, specifySize: LGEtruefalse