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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K251292
Device Name RECLAIM Monobloc Revision Femoral Stem
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Robin Layton
Correspondent
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Correspondent Contact Robin Layton
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/25/2025
Decision Date 05/23/2025
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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