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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 K250989
Device Name Stryker and Serf hip devices
Applicant
Howmedica Osteonics Corp (Dba Stryker Orthopaedics)
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Gregg Ritter
Correspondent
Howmedica Osteonics Corp (Dba Stryker Orthopaedics)
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Gregg Ritter
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
HWC   KWZ   LZO   MAY   MBL  
MEH  
Date Received03/31/2025
Decision Date 07/25/2025
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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