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: Patella prosthesis trial FDA UDI
Device Name: Patellar trial, asymmetric onset, NON-CEM, XL FDA UDI
Model / Reference: 2403-6650 FDA UDI
Description: Patellar trial, asymmetric onset, NON-CEM, XL FDA UDI

Identifiers

Catalog Number: 2403-6650 FDA UDI
Primary DI / UDI-DI: 04719886903744 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
KRO FDA UDI
GMDN Term: Patella prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
888.3510 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Patella prosthesis trial

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 Patella prosthesis trial.

Unity Knee System — OMNIlife science, Inc. · Class I
BIOMET SERIES A — Biomet Orthopedics, Inc. · Class II
EXULT Knee Replacement System — Corentec Co., Ltd · Class II
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I

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 ffa40ee0-731c-420b-9468-f3cffeb3b6b5 35 fields · synced Jun 8, 2026