510(k) K211671

Journey II Mid-Level Tibial Inserts by Smith & Nephew, Inc. — Product Code JWH

K211671 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Journey II Mid-Level Tibial Inserts". The FDA issued a decision of Substantially Equivalent on Aug 17, 2021. 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. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.