510(k) K202022

GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) by Medacta International S.A. — Product Code JWH

K202022 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)". The FDA issued a decision of Substantially Equivalent on Sep 18, 2020. 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. Medacta International S.A. has 207 other 510(k) clearances on record.