510(k) K210010

GMK Revision & Hinge Extension - TiNbN Coating by Medacta International S.A. — Product Code KRO

K210010 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK Revision & Hinge Extension - TiNbN Coating". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Medacta International S.A. has at least 10 other 510(k) clearances on record.