BIOMETRIC TOTAL HIP SYSTEM— 510(k) K844787

Substantially Equivalent

Biomedics

FDA 510(k) clearance K844787 for BIOMETRIC TOTAL HIP SYSTEM, Substantially Equivalent on 1985-04-19. Applicant: Biomedics.

Clearance details

Applicant: Biomedics
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1984-12-10
Decision date: 1985-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.