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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, Cemented
510(k) Number K243571
Device Name Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
Applicant
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Sean Gleason
Correspondent
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Sean Gleason
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
KWZ  
Date Received11/18/2024
Decision Date 07/31/2025
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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