Arthrex iBalance UKA System Vitamin E Tibial Bearing— 510(k) K161060

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K161060 for Arthrex iBalance UKA System Vitamin E Tibial Bearing, Substantially Equivalent on 2016-12-15. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2016-04-15
Decision date: 2016-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.