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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 K212411
Device Name Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Applicant
Conformis, Inc.
600 Technology Park Dr., 4th Floor
Billerica,  MA  01821
Applicant Contact Kara Johnson
Correspondent
Conformis, Inc.
600 Technology Park Dr., 4th Floor
Billerica,  MA  01821
Correspondent Contact Kara Johnson
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received08/03/2021
Decision Date 09/23/2021
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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