510(k) K122883

EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM by Stelkast Company — Product Code JWH

K122883 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 2013. 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 Company has at least 10 other 510(k) clearances on record.