510(k) K220049

Optimotion Implants Porous Metal-Backed Patella by Optimotion Implants, LLC — Product Code MBH

K220049 is an FDA 510(k) premarket notification submitted by Optimotion Implants, LLC for the device "Optimotion Implants Porous Metal-Backed Patella". The FDA issued a decision of Substantially Equivalent on Mar 14, 2022. 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.