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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K240475
Device Name Hintermann Series H2 Total Ankle System
Applicant
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact Jessica Johnson
Correspondent
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Correspondent Contact Chris Weaber
Regulation Number888.3110
Classification Product Code
HSN  
Date Received02/20/2024
Decision Date 12/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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