X-PSI Knee System— 510(k) K171269

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K171269 for X-PSI Knee System, Substantially Equivalent on 2017-12-28. Applicant: Orthosoft Inc (D/B/A Zimmer Cas).

Clearance details

Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2017-05-01
Decision date: 2017-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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.