510(k) K230846

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System by Conformis, Inc. — Product Code JWH

K230846 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System". The FDA issued a decision of Substantially Equivalent on July 17, 2023. 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.