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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
510(K) Number K111433
Device Name DEPUY STTUNE (TM) PS KNEE SYSTEM
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
Warsaw, IN 46581 -0988
Applicant Contact Nancy Friddle
Correspondent DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
Warsaw, IN 46581 -0988
Correspondent Contact Nancy Friddle
Regulation Number 888.3560
Classification Product Code OIY  
Subsequent Product Code JWH  
Date Received 05/23/2011
Decision Date 08/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed By Third Party No
Combination Product No
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Page Last Updated: 02/18/2019

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