510(k) K230555

Cemented Tibia Baseplate no Taper with JRNY Lock by Smith & Nephew, Inc. — Product Code JWH

K230555 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Cemented Tibia Baseplate no Taper with JRNY Lock". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. 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.