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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K253551
Device Name VELYS™ Hip Navigation
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy, Co. Cork,  IE
Applicant Contact Erin Combs
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy, Co. Cork,  IE
Correspondent Contact Anuradha Moholkar
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/14/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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