510(k) K210252

iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System by Conformis, Inc. — Product Code JWH

K210252 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System". The FDA issued a decision of Substantially Equivalent on February 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. Conformis, Inc. has at least 10 other 510(k) clearances on record.