| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Hintermann Series H3 Total Ankle Replacement System |
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| Generic Name | Prosthesis, ankle, uncemented, non-constrained |
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| Applicant | DT MedTech LLC
110 West Road
Suite 227
Towson, MD 21204 |
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| PMA Number | P160036 |
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| Date Received | 08/24/2016 |
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| Decision Date | 06/04/2019 |
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| Product Code |
NTG |
| Docket Number | 19M-2732 |
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| Notice Date | 06/25/2019 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the Hintermann Series H3 Total Ankle Replacement System. The device is 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 device system is for prescription use. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 |
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