Cleared Traditional

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

K252824 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Mar 2026
Decision
188d
Days
-
Risk

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 West, AU). The FDA issued a Cleared decision on March 12, 2026 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Signature Orthopaedics Pty, Ltd. devices

Submission Details

510(k) Number K252824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -