Journey

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: JOURNEY FDA UDI
Generic Name: Uncoated unicondylar knee femur prosthesis FDA UDI
Device Name: JOURNEY II UK OXINIUM FEMORAL SIZE 1 LEFT MEDIAL/RIGHT LATERAL FDA UDI
Model / Reference: 74026021 FDA UDI
Description: JOURNEY II UK OXINIUM FEMORAL SIZE 1 LEFT MEDIAL/RIGHT LATERAL FDA UDI

Identifiers

Catalog Number: 74026021 FDA UDI
Primary DI / UDI-DI: 00885556675045 FDA UDI
510(k) Number: K190085 FDA UDI
K230653 FDA UDI
K242711 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Uncoated unicondylar knee femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Uncoated unicondylar knee femur prosthesis

Journey by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated unicondylar knee femur prosthesis.

HLS Uni Evolution — CORIN LTD · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
iUni® Femoral Kit — Conformis, Inc. · Class II
Persona® Partial Knee System — Biomet Orthopedics, Inc. · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
AS univation® XF — AESCULAP, INC. · Class II

Cleared under the same submission

K190085 also covers:

K230653 also covers:

K242711 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI b9bc13ec-12a2-4466-bc0c-480d15aa9eec 37 fields · synced Jun 8, 2026