Cleared Traditional

K252824 - Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

K252824 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K252824

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 - Class ,

Product Code -
Device Class -