510(k) K252824

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head by Signature Orthopaedics Pty, Ltd. — Product Code JDI

K252824 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.