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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 K262341
Device Name b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
Applicant
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Applicant Contact Allison Gecik
Correspondent
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Correspondent Contact Allison Gecik
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received07/10/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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