Active-V Total Knee System; World Total Knee System— 510(k) K253239

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K253239 for Active-V Total Knee System; World Total Knee System, Substantially Equivalent on 2025-12-23. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2025-09-29
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.