510(k) K191084

The Optimotion Blue Total Knee System by Optimotion Implants, LLC — Product Code MBH

K191084 is an FDA 510(k) premarket notification submitted by Optimotion Implants, LLC for the device "The Optimotion Blue Total Knee System". The FDA issued a decision of Substantially Equivalent on Apr 7, 2020. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Optimotion Implants, LLC has at least 2 other 510(k) clearances on record.