510(k) K213673

b-ONE MOBIO Total Knee System by B-One Ortho, Corp. — Product Code JWH

K213673 is an FDA 510(k) premarket notification submitted by B-One Ortho, Corp. for the device "b-ONE MOBIO Total Knee System". The FDA issued a decision of Substantially Equivalent on January 21, 2022. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. B-One Ortho, Corp. has at least 10 other 510(k) clearances on record.