Journey

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: JOURNEY FDA UDI
Generic Name: Unicondylar knee insert FDA UDI
Device Name: JOURNEY II UK XLPE TIBIA INSERT MEDIAL SIZE 7-8 8MM FDA UDI
Model / Reference: 74026178 FDA UDI
Description: JOURNEY II UK XLPE TIBIA INSERT MEDIAL SIZE 7-8 8MM FDA UDI

Identifiers

Catalog Number: 74026178 FDA UDI
Primary DI / UDI-DI: 00885556677209 FDA UDI
510(k) Number: K190085 FDA UDI
K230653 FDA UDI
K242711 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Unicondylar knee insert 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: Unicondylar knee insert

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

Similar devices

Also classified as Unicondylar knee insert.

Alliant Biotech — Medisurge · Class II
Vivacit-E® — Zimmer, Inc. · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
MOTO Partial Knee System - Medial — Medacta International · Class II
GMK Uni — Medacta International · Class II
SIGMA — DEPUY (IRELAND) · Class II
MOTO Partial Knee System — Medacta International · Class II
iDuo® iPoly™ Insert Kit — Conformis, 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 0a56a452-1754-4617-9d8d-0f0bc1ffe4bd 38 fields · synced Jun 8, 2026