c08bbcb2-1f5e-4fb5-bb87-c5c852d91726UpdatePublished42020-03-052016-11-17In Commercial Distribution07340152100580PrimaryGS1OPRA Implant System13591359356739813Integrum AB1Healing Screw C5falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+46317601060info@integrum.seH08000400058743Internal-external leg prosthesis osseointegration barA rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).trueActivePJYTransfemoral Percutaneous ProsthetictruetrueRadiation Sterilization