510(k) K243295

Initia Knee System by Kyocera Medical Technologies, Inc. — Product Code JWH

K243295 is an FDA 510(k) premarket notification submitted by Kyocera Medical Technologies, Inc. for the device "Initia Knee System". The FDA issued a decision of Substantially Equivalent on January 13, 2025. 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. Kyocera Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.