510(k) K190122

Renovis A200 PS Knee System as part of the Renovis A200 Knee System by Renovis Surgical Technologies — Product Code JWH

K190122 is an FDA 510(k) premarket notification submitted by Renovis Surgical Technologies for the device "Renovis A200 PS Knee System as part of the Renovis A200 Knee System". The FDA issued a decision of Substantially Equivalent on June 20, 2019. 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. Renovis Surgical Technologies has at least 10 other 510(k) clearances on record.