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510(k) K222653

Device
JOURNEY II UK™ And ENGAGE™ Cementless Partial Knee System
Applicant
Smith+Nephew, Inc
510(k) number
K222653
Product code
NJD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-28
Date received
2022-09-01
Regulation
888.3535
Classification name
Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lilian Hren
Address
1450 Brooks Rd. Memphis TN US 38116 38116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NJD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion2025-09-02
K242307ACHIEVE Partial Knee SystemIgnite Orthomotion2024-12-16
K190439Engage™ Partial Knee SystemEngage Uni, LLC2019-11-21
K133811RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corp.2014-07-08

Legacy Summary#

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FDA Review#

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