World Hip Stem, World Cup, World Liner— 510(k) K201278

Name: FDA 510(k) clearance K201278
Creator: U.S. Food and Drug Administration
Published: 2020-09-21

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K201278 for World Hip Stem, World Cup, World Liner, Substantially Equivalent on 2020-09-21. Applicant: Signature Orthopaedics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2020-05-13
Decision date: 2020-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

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K243021 — Longboard Revision Hip Stem2025-08-07
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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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