510(k) K173875

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert by Stelkast, Inc. — Product Code JWH

K173875 is an FDA 510(k) premarket notification submitted by Stelkast, Inc. for the device "GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert". The FDA issued a decision of Substantially Equivalent on January 19, 2018. 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. Stelkast, Inc. has at least 10 other 510(k) clearances on record.