1. The first post-approval study is designed to evaluate the long-term safety and effectiveness of the star ankle among patients who participated in the continued access cohort (cac) under the investigational device exemption (ide) study. A prospective, multi-center, single arm study design with hypothesis testing will be used to determine the 8-year survivorship and effectiveness of arthroplasty using the star ankle in comparison to ankle arthrodesis from historical literature controls. The study population will consist of all living subjects who participated in the continued access cohort, regardless of whether or not the patient has had a revision/removal with at least 250 star ankle patients followed through the 4-year visit and a minimum of 100 star ankle patients followed through the 8-year post-operation visit. Patients will undergo clinical and radiographic evaluation postoperatively at 4, 6 and 8 years. The baseline, 6week, 1-year and 2-year data will be used as collected in the continued access cohort during the ide study. Data on ankle arthrodesis controls identified by a systematic review of the literature will be summarized. You have agreed to take reasonable measures to avoid loss to follow-up. You have agreed to collect information about any reoperation, revisions or removals of the star ankle device, and effectiveness endpoints, including total buechel-pappas scale score, pain visual analog scale (vas), quality of life (sf-36) and aofas, and radiographic endpoints (radiolucency and migration). You have also agreed to 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. Every six months for the first two years and then annually until the study is completed you are to submit a progress report to the fda that includes, but is not limited to, the status of site enrollment, the status of patient enrollment, the status of patient follow-up, and other milestones as it compares to the stated goals in the protocol and an explanation for a delay, if any in meeting these goals, and the safety and effectiveness data collected during that reporting period. You must also update your patient and physician labeling (via a pma supplement) to reflect the 4, 6 and 8 year findings, as soon as these data are available, as well as any other timepoint deemed necessary by fda if significant new information from this study becomes available.
| Device | Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | DJO Global |
| Date Received | 2021-07-09 |
| Decision Date | 2021-08-23 |
| PMA | P050050 |
| Supplement | S019 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DJO Global 9800 Metric Boulevard austin, TX 78758 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050050 | | Original Filing |
| S025 |
2022-09-02 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 |
2022-02-01 |
30-day Notice |
| S021 | | |
| S020 |
2021-11-19 |
Special (immediate Track) |
| S019 |
2021-07-09 |
Normal 180 Day Track No User Fee |
| S018 |
2021-03-24 |
30-day Notice |
| S017 |
2021-02-16 |
30-day Notice |
| S016 |
2020-12-14 |
30-day Notice |
| S015 |
2020-11-02 |
30-day Notice |
| S014 |
2020-08-03 |
30-day Notice |
| S013 | | |
| S012 |
2018-08-21 |
Real-time Process |
| S011 |
2017-10-10 |
Real-time Process |
| S010 |
2016-07-12 |
Real-time Process |
| S009 | | |
| S008 |
2016-04-11 |
Normal 180 Day Track No User Fee |
| S007 |
2014-03-11 |
Normal 180 Day Track No User Fee |
| S006 |
2014-03-10 |
Real-time Process |
| S005 |
2012-11-13 |
Special (immediate Track) |
| S004 |
2012-09-04 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2009-08-21 |
Normal 180 Day Track No User Fee |
| S001 |
2009-08-05 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices