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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K261576
Device Name Icona Hip Stem
Applicant
Corin, Ltd.
The Corinium Centre
Cirencester,  GB GL7 1YJ
Applicant Contact Aaron Brunt
Correspondent
Corin, Ltd.
The Corinium Centre
Cirencester,  GB GL7 1YJ
Correspondent Contact Aaron Brunt
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   KWY   LPH   LZO  
Date Received05/12/2026
Decision Date 08/10/2026
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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