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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K172501
Device Name iNSitu Total Hip System
Applicant
Theken Companies, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Dale Davison
Correspondent
Theken Companies, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Correspondent Contact Dale Davison
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   OQG   OQI  
Date Received08/18/2017
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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