Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
DT MedTech, LLC
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.
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. (OU…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator. * Willingness to participate in the study and follow-up visits * Written informed consent, including authorization to release collected health data Exclusion Criteria: * Skeletal immaturity * Bone stock inadequate to support the device including: * Severe osteoporotic or osteopenic condition or other conditions resulting in poor b…
Interventions
- DeviceHintermann Series H3 Total Ankle Replacement System
Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.
Locations (10)
- Los Angeles Institute of Foot and Ankle SurgeryMission Hills, California
- Florida Orthopedic Foot & Ankle CenterSarasota, Florida
- Paley Orthopedic & Spine InstituteWest Palm Beach, Florida
- Orthopaedic AssociatesEvansville, Indiana
- Department of Orthopedic Surgery, Johns Hopkins Outpatient CenterBaltimore, Maryland
- New Mexico Bone and Joint InstituteAlamogordo, New Mexico