Vanguard Patella Component

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Vanguard Patella Component FDA UDI
Generic Name: Patella prosthesis trial FDA UDI
Model / Reference: SSI003965 FDA UDI

Identifiers

Catalog Number: SSI003965 FDA UDI
Primary DI / UDI-DI: 00880304992382 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: Height — 40 Millimeter FDA UDI

Category: Patella prosthesis trial

Vanguard Patella Component by Biomet Orthopedics, 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
EXULT Knee Replacement System — Corentec Co., Ltd · Class II
Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
JOURNEY — Smith & Nephew, Inc. · Class II
Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I
LCS — DEPUY ORTHOPAEDICS, INC. · Class I
LinkSymphoKnee - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
PROFIX — Smith & Nephew, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 5e15b90d-d8a5-475b-aba3-21f5da5bd025 35 fields · synced Jun 1, 2026