Arthrex iBalance Patella Implant, Dome— 510(k) K143047

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K143047 for Arthrex iBalance Patella Implant, Dome, Substantially Equivalent on 2014-11-19. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2014-10-23
Decision date: 2014-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, 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.