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# PMA Approved for Above Knee Amputee Implant
- URL: https://www.fdaweb.com/pma-approved-for-above-knee-amputee-implant/
- Published: 2020-12-18T12:00:00.000Z
- Updated: 2026-09-14T16:40:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148341

FDA has approved an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for adults who have transfemoral (above-the-knee) amputations and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The device is surgically anchored and integrated into a patient’s remaining thigh bone to allow connection to an external prosthetic limb. It has been on the market under a [humanitarian device exemption](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3ObBGwARcrpaEy3HfN-2FdEluVkxmG5JCX49zFTqYJ8DsyL5w8WzS7itfnueiTsC5oToGp-2B5odGPDt-2FtJWW47MAlgcWtQ%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVHa21dOewZdGzyIgNi5YHVdzAzRSlA32Ux1OgwwfmGDZNv8FpRMqK1J8Uq3VxRLsYRaUYlFZZR4dEQkAdkHluf9AABVApgrHBWU5jwYS1jpqs7DF0EPQ6q70WwY7faGxmTgCsCijhmjEwuc-2FyPY48HOzMMcCrQUqgrMbwN9VTRpyQ7b6zWQvs8uj9lb5UCVePCi-2FM3y27OsjA17an67u39cGyhJnqlxw-2BEtOJ6wa-2BnUWkxpG4xaAE-2B4-2F42vo-2BXLaTCc13RSSxV50A2eXlFCRRb9XfU95nODCeI-2Bn7aMVFD5s-3D&ref=fdaweb.com) since 2015.

The implant is installed through two surgical procedures. “In the first procedure, a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone,” [FDA says](https://www.fda.gov/news-events/press-announcements/fda-approves-prosthetic-implant-above-knee-amputations?ref=fdaweb.com). “Approximately six months later, after tissue has grown to anchor the fixture and the skin tissue has healed, a second surgery is performed to attach additional device components of the OPRA Implant System to the fixture from the previous surgery.”