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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 K191084
Device Name The Optimotion Blue Total Knee System
Applicant
Optimotion Implants, LLC
5931 Brick Ct.
Suite 130
Winter Park,  FL  32792
Applicant Contact Dan Justin
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-Llle-Perrot,  CA J7V7P2
Correspondent Contact Robert A Poggie
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received04/24/2019
Decision Date 04/07/2020
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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