Osseointegrated Transtibial Prosthesis With Neural Interface

Inclusion Criteria: * Male or Female age 22-65 at the time of surgery. * The patient must have an existing unilateral or bilateral transtibial amputation or a medical condition requiring performance of a unilateral or bilateral transtibial amputation with a minimum of 8 cm of residual tibia after amputation. * The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition. * The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above). * The patient must have adequate bone stock to support the implanted device. * The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing and muscle end organ construction. * In the opinion of the investigator, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate. * Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program. * Written informed consent to participate in the study provided by the patient or legal representative. Exclusio…