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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 K121393
Device Name SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact GINO ROUSS
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact GINO ROUSS
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
HRY   HSX   JWH   KRO   KRQ  
KRR   NPJ  
Date Received05/09/2012
Decision Date 08/07/2012
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
Recalls CDRH Recalls
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