510(k) K162026

EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions by Microport Orthopedics, Inc. — Product Code JWH

K162026 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions". The FDA issued a decision of Substantially Equivalent on Mar 1, 2017. 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. Microport Orthopedics, Inc. has 38 other 510(k) clearances on record.