Overview: The SurgTech GENOLLTM Total Knee Arthroplasty System (TKA) is used for primary total knee replacement in skeletally mature individuals. The system consists of GENOLL™PS FEMORAL COMPONENT, GENOLL™ TIBIAL BASEPLATE, GENOLL™PS TIBIAL INSERT & GENOLL™ 3-PEG PATELLA. Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patello femorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 29, 2019 Received: May 3, 2019