510(k) K190562

iTotal Identity Cruciate Retaining Knee Replacement System by Conformis, Inc. — Product Code JWH

K190562 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "iTotal Identity Cruciate Retaining Knee Replacement System". The FDA issued a decision of Substantially Equivalent on Aug 8, 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. Conformis, Inc. has 59 other 510(k) clearances on record.