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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHintermann Series H3 Total Ankle Replacement System
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDt Medtech, LLC
110 W. Rd.
Suite 227
Towson, MD 21204
PMA NumberP160036
Date Received08/24/2016
Decision Date06/04/2019
Product Code NTG 
Docket Number 19M-2732
Notice Date 06/25/2019
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S008 
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