510(k) K213071

MOTOTM Partial Knee & MOTO PFJ Systems Extension by Medacta International S.A. — Product Code HSX

K213071 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MOTOTM Partial Knee & MOTO PFJ Systems Extension". The FDA issued a decision of Substantially Equivalent on November 16, 2021. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Medacta International S.A. has at least 10 other 510(k) clearances on record.