EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)— 510(k) K161945

Name: FDA 510(k) clearance K161945
Creator: U.S. Food and Drug Administration
Published: 2016-09-23

Substantially Equivalent

Encore Medical L.P.

FDA 510(k) clearance K161945 for EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm), Substantially Equivalent on 2016-09-23. Applicant: Encore Medical L.P.. Device class: 2.

Clearance details

Applicant: Encore Medical L.P.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2016-07-15
Decision date: 2016-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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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.