510(k) K253239

Active-V Total Knee System; World Total Knee System by Signature Orthopaedics Pty, Ltd. — Product Code MBH

K253239 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Active-V Total Knee System; World Total Knee System". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.