U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella— 510(k) K243656

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K243656 for U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella, Substantially Equivalent on 2025-07-31. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2024-11-26
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

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.