UNITY TOATAL KNEE SYSTEM— 510(k) K113060

Substantially Equivalent

Corin USA

FDA 510(k) clearance K113060 for UNITY TOATAL KNEE SYSTEM, Substantially Equivalent on 2012-09-10. Applicant: Corin USA.

Clearance details

Applicant: Corin USA
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2011-10-14
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.