ACTIVE UNICOMPARTMENTAL KNEE SYSTEM— 510(k) K060412

Substantially Equivalent

Australian Surgical Design & Manufacture

FDA 510(k) clearance K060412 for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM, Substantially Equivalent on 2006-05-17. Applicant: Australian Surgical Design & Manufacture.

Clearance details

Applicant: Australian Surgical Design & Manufacture
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2006-02-16
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.