The second post-approval study (pas002, hintermann series h3 tar performance study) is designed to evaluate the trend in performance between each implant size and assess the outcomes of the primary surgeon of the study (accounting for approximately 80% of the registry) compared to other surgeons that are less familiar with the device. You agree to use a prospective, multicenter, single arm study design, and hypothesis testing to evaluate the performance of the different implant sizes of the hintermann series h3 tar system compared to the hintermann series h3 tar system performance in the pse cohort. Multiple investigators unfamiliar with the device will be recruited so that one surgeon does not conduct the majority of the cases and to evaluate the impact of experience on overall outcomes. You have agreed to enroll 232 new study subjects at up to 10 us sites and to follow these subjects for 5 years. Study subjects will undergo clinical and radiographic evaluation postoperatively at 6 weeks, 6 months, and yearly afterwards. You have agreed to take reasonable measures to avoid loss to follow-up. A follow-up rate of 85% is expected at each timepoint. You have agreed to collect and analyze information about safety, including any reoperation, revisions or removals of the hintermann ankle device, and effectiveness endpoints, including the american orthopaedic foot and ankle society at 2 years or more, the survivorship (absence of removal/revisions to include polyethylene revision) within 5 years, the percentage of subjects with a serious device-related adverse event other than a revision or removal within 2 years, as well as vas score, patient satisfaction, and sf-36 for general well-being. You will also collect information about all adverse events reported for these patients, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome. Additionally, you have agreed to provide radiographic assessments of all enrolled subjects as well as a detailed explant analysis of any explanted devices during the pas.
| Device | Hintermann Series H3 Total Ankle Replacement System |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | DT MedTech LLC |
| Date Received | 2021-09-10 |
| Decision Date | 2021-10-15 |
| PMA | P160036 |
| Supplement | S003 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DT MedTech LLC 110 West Road suite 227 towson, MD 21204 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160036 | | Original Filing |
| S003 |
2021-09-10 |
Normal 180 Day Track No User Fee |
| S002 |
2021-02-26 |
30-day Notice |
| S001 |
2019-07-01 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices