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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K080936
Device Name CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
Applicant
Conformis, Inc.
2 Fourth Ave.
Burlington,  MA  01803
Applicant Contact S. MICHAEL SHARP
Correspondent
Conformis, Inc.
2 Fourth Ave.
Burlington,  MA  01803
Correspondent Contact S. MICHAEL SHARP
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/02/2008
Decision Date 05/12/2008
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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