Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides— 510(k) K150928

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K150928 for Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides, Substantially Equivalent on 2015-08-10. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2015-04-06
Decision date: 2015-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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.