JOURNEY II UK™ And ENGAGE™ Cementless Partial Knee System

Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

Smith+Nephew, Inc

The following data is part of a premarket notification filed by Smith+nephew, Inc with the FDA for Journey Ii Uk™ And Engage™ Cementless Partial Knee System.

Pre-market Notification Details

Device IDK222653
510k NumberK222653
Device Name:JOURNEY II UK™ And ENGAGE™ Cementless Partial Knee System
ClassificationProsthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Applicant Smith+Nephew, Inc 1450 Brooks Rd Memphis,  TN  38116
ContactLilian Hren
CorrespondentLilian Hren
Smith+Nephew, Inc 1450 Brooks Rd Memphis,  TN  38116
Product CodeNJD  
CFR Regulation Number888.3535 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-01
Decision Date2022-10-28

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