KINETIS Total Knee System— 510(k) K143635

Substantially Equivalent

Mako Surgical

FDA 510(k) clearance K143635 for KINETIS Total Knee System, Substantially Equivalent on 2015-02-20. Applicant: Mako Surgical.

Clearance details

Applicant: Mako Surgical
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2014-12-22
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, 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.