Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Hintermann Series H3 Total Ankle Replacement System
• Generic Name: Prosthesis, ankle, uncemented, non-constrained
• Applicant: Dt Medtech, LLC; 110 W. Rd.; Suite 227; Towson, MD 21204
• PMA Number: P160036
• Supplement Number: S003
• Date Received: 09/10/2021
• Decision Date: 10/15/2021
• Product Code: NTG
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.