510(k) K222380

TriVerse Total Knee Replacement System by Signature Orthopaedics Pty, Ltd. — Product Code JWH

K222380 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "TriVerse Total Knee Replacement System". The FDA issued a decision of Substantially Equivalent on October 4, 2022. 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. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.