• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceHintermann Series H3 Total Ankle Replacement System
Classification Nameprosthesis, ankle, uncemented, non-constrained
Generic Nameprosthesis, ankle, uncemented, non-constrained
Applicant
DT MedTech LLC
110 west road
suite 227
towson, MA 21204
PMA NumberP160036
Date Received08/24/2016
Decision Date06/04/2019
Product Code
NTG[ Registered Establishments with NTG ]
Docket Number 19M-2732
Notice Date 06/25/2019
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-