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FDA 510(k)

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

K-Number: K242711 · 2024-10-30

ApplicantSmith & Nephew, Inc.
Decision Date2024-10-30
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-10-30 under approval number K242711. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is a medical device that received FDA 510(k) clearance on 2024-10-30. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K242711.

When was JOURNEY II Unicompartmental Knee System (JOURNEY II UK) approved by the FDA?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) received FDA 510(k) clearance on 2024-10-30, under approval number K242711.

What company makes JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is manufactured by Smith & Nephew, Inc..

What is the FDA product code for JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

The FDA product code for JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is HSX.

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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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