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Osseointegrated (OI) limb prostheses have existed since the early 1990’s but have only recently been introduced in the United States. In 2015, the Food and Drug Administration (FDA) gave Humanitarian Device Exemption approval for the surgical procedure and components associated with this technology has allowed for commercial distribution of OI prostheses. Apply for FDA Approval on their website. ABC certified prosthetists are beginning to treat patients who have had an osseointegration procedure.
Orthotic and/or prosthetic care provided by ABC certified professionals does not include independent provision of invasive procedures; however, certified prosthetists do play a role in the provision of OI prostheses. Once the surgical procedure has been completed and the surgeon has cleared the patient for weight bearing, the certified prosthetist evaluates the individual for the provision of the prosthesis.
This type of prosthetic intervention has unique requirements concerning the type of connector component used with the external adapter (sometimes called the abutment). Consistent with ABC’s accreditation standards, the certified prosthetist must follow the specific manufacturer’s guidelines for the use of the connector associated with the OI component.
Beyond this special consideration, the existing ABC scope of practice guidelines for the provision prosthetic care remain the same.