U2 Total Knee System

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: U2 Total Knee System FDA UDI
Generic Name: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: Patella, Onset, E-XPE, PF+, Small, 29mm Dia. 9mm Thick FDA UDI
Model / Reference: 2403-5420 FDA UDI
Description: Patella, Onset, E-XPE, PF+, Small, 29mm Dia. 9mm Thick FDA UDI

Identifiers

Catalog Number: 2403-5420 FDA UDI
Primary DI / UDI-DI: 04719886896367 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
KRO FDA UDI
GMDN Term: Cruciate-retaining total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
888.3560 FDA UDI
888.3510 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

FDA UDI

Category: Posterior-stabilized total knee prosthesis Cruciate-retaining total knee prosthesis Rotating hinged total knee prosthesis

U2 Total Knee System by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rotating hinged total knee prosthesis.

TRIATHLON — Howmedica Osteonics Corp. · Class II
LEGION — Smith & Nephew, Inc. · Class II
AS ENDURO — AESCULAP, INC. · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
ATTUNE LPS — DEPUY (IRELAND) · Class II
TRIATHLON — Howmedica Osteonics Corp. · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
LEGION — Smith & Nephew, Inc. · Class II

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: United Orthopedic Corp.

Sources (1)

FDA UDI fa319a60-54e3-4ceb-84cf-dbfab0d72786 35 fields · synced May 30, 2026