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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 K242084
Device Name EMPHASYS Acetabular Shell with RapiTite HA
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Ringaskiddy
Cork,  IE
Applicant Contact Elaine Pears
Correspondent
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Correspondent Contact Elaine Pears
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received07/16/2024
Decision Date 10/07/2024
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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