510(k) K892366

POROUS GENESIS STEMMED TIBIAL COMPONENT by Richards Medical Co., Inc. — Product Code JWH

K892366 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "POROUS GENESIS STEMMED TIBIAL COMPONENT". The FDA issued a decision of SN on July 19, 1989. 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. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.