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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
Recalls CDRH Recalls
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