NovoKnee Total Knee System

FDA UDI

Class II (US FDA UDI)

by Novosource, Inc.

Identity

Trade Name: NovoKnee Total Knee System FDA UDI
Generic Name: Patella prosthesis trial FDA UDI
Device Name: Patella 32mm Trial FDA UDI
Model / Reference: 3411-0070 FDA UDI
Description: Patella 32mm Trial FDA UDI

Identifiers

Catalog Number: 3411-0070 FDA UDI
Primary DI / UDI-DI: 00811382036859 FDA UDI
510(k) Number: K123339 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Patella prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 32 Millimeter FDA UDI

Category: Patella prosthesis trial

NovoKnee Total Knee System by Novosource, Inc. — 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

Cleared under the same submission

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: Novosource, Inc.

Sources (1)

FDA UDI 0920092e-5a6b-4dd3-b13c-b48ad33c04a8 37 fields · synced Jun 8, 2026