Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head— 510(k) K252824

Name: FDA 510(k) clearance K252824
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K252824 for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head, Substantially Equivalent on 2026-03-12. Applicant: Signature Orthopaedics Pty, Ltd..

Summary

Signature Orthopaedics' record names four parts: the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head. They're filed under JDI, semi-constrained cemented metal/polymer hip prostheses.

Class II, 21 CFR 888.3350. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Signature Orthopaedics filed from Lane Cove West, Australia. The decision came 188 calendar days after FDA received it (September 5, 2025 to March 12, 2026).

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Advisory panel: Unknown
Date received: 2025-09-05
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.