510(k) K193105

iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System by Conformis, Inc. — Product Code JWH

K193105 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System". The FDA issued a decision of Substantially Equivalent on March 13, 2020. 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.