The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361). This will be a Prospective, single-center, single arm study.
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AOFAS Score Measurement
Timeframe: 10 Years
Survivorship Measurement
Timeframe: 10 Years
Serious device-related adverse event Measurement
Timeframe: 10 Years
Reoperation, revisions or removals Measurement
Timeframe: 10 Years
Serious Device-Related Adverse Events Measurement
Timeframe: 10 Years
Device Explant Analysis Measurement
Timeframe: Through Study Completion an Average of 10 years