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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 K252401
Device Name implaFit® short stems
Applicant
Implantcast GmbH
Lüneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliane Höppner
Correspondent
Mcra, LLC
803 7th St. NW, 4th Floor
Washington,  DC  20001
Correspondent Contact Ryan Sexton
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   MEH  
Date Received07/31/2025
Decision Date 03/12/2026
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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