OPRA™ Implant System Abutment 12x78 +4

Device typeInternal-external leg prosthesis osseointegration bar: A 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).

FDA categoryOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Device ID07340152102140

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyMR Safe