DePuy Synthes Variable Angle Locking Patella Plating System— 510(k) K201578

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K201578 for DePuy Synthes Variable Angle Locking Patella Plating System, Substantially Equivalent on 2020-09-09. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-06-11
Decision date: 2020-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.