9460d295-39fa-4825-967c-550a6cbcca0fUpdatePublished32018-07-062015-10-24In Commercial DistributionB033KCS61PrimaryHIBCCSeitz Solution Unlar HeadKCS-61KCS-61004171112Kapp Surgical Instrument Co.16.5x1mm SpacerfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK03393000033720Wrist ulna-head prosthesisA sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.trueActiveKXEProsthesis, Wrist, Hemi-, UlnarfalsetrueMoist Heat or Steam Sterilization