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FDA 510(k)

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System

K-Number: K222653 · 2022-10-28

ApplicantSmith+Nephew, Inc.
Decision Date2022-10-28
Product CodeNJD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is a medical device manufactured by Smith+Nephew, Inc.. It received FDA 510(k) clearance on 2022-10-28 under approval number K222653. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Smith+Nephew, Inc.. The 510(k) number is K222653.

When was JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System approved by the FDA?

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System received FDA 510(k) clearance on 2022-10-28, under approval number K222653.

What company makes JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is manufactured by Smith+Nephew, Inc..

What is the FDA product code for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?

The FDA product code for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is NJD.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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