Cleared Traditional

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

K252824 · Signature Orthopaedics Pty, Ltd. · Orthopedic

Mar 2026

Decision

188d

Days

—

Risk

About This 510(k) Submission

K252824 is an FDA 510(k) clearance for the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head, submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove, AU). The FDA issued a Cleared decision on March 12, 2026, 188 days after receiving the submission on September 5, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K252824 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2025
Decision Date	March 12, 2026
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF