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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
510(k) Number K222653
Device Name JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
Applicant
Smith+Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact Lilian Hren
Correspondent
Smith+Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Lilian Hren
Regulation Number888.3535
Classification Product Code
NJD  
Subsequent Product Code
HSX  
Date Received09/01/2022
Decision Date 10/28/2022
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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