510(k) K213389

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

K213389 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System". The FDA issued a decision of Substantially Equivalent on November 10, 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.