Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
brief summary
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
detailed description
The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).
The present version (third generation) of the H3 TAR and the earlier generations of this total ankle system have been marketed (initially in 2003) under a license agreement in Europe, South Korea, Australia, and Canada and other countries outside the U.S. (OUS). The H3 TAR prosthesis has been used in over 20,000 procedures in the markets OUS. The H3 TAR device has not been withdrawn from marketing for any reason.
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
official title
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System