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# Review Period Determined on Ankle System
- URL: https://www.fdaweb.com/review-period-determined-on-ankle-system/
- Published: 2021-03-16T12:00:00.000Z
- Updated: 2026-09-14T16:50:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148886

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for DT MedTech’s Hintermann Series H3 Total Ankle Replacement System, 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 review period was determined to be 4,676 days, which includes 3,661 days that occurred during the testing phase and 1,015 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-16/pdf/2021-05371.pdf?ref=fdaweb.com).