510(k) K212411

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

K212411 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)". The FDA issued a decision of Substantially Equivalent on September 23, 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.