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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K211221
Device Name Porous Patella and Porous Tibia Baseplate
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Brad Sheals
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Brad Sheals
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/23/2021
Decision Date 10/01/2021
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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