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Vanguard Knee System Titanium Femoral Components

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080204

by Biomet, Inc.

Identifiers

510(k) Number
K080204 FDA 510(k)
FDA Product Code
JWH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vanguard Knee System Titanium Femoral Components are a type of femoral knee replacement made from titanium alloy, designed for patients with nickel sensitivity to cobalt-chromium alloys. They are intended for total knee arthroplasty and have the same design as the predicate Vanguard femoral components. The device is used in orthopedic surgery to replace the femoral component of the knee joint.

The Vanguard Knee System Titanium Femoral Components are supplied in ten femoral sizes and are designed for use with bone cement fixation. They are part of the Vanguard Complete Knee System, which offers complete femoral/tibial size interchangeability and two bearing options. The device has received FDA 510K authorization and is classified under product code JWH.

Frequently asked questions

What material are the Vanguard Knee System Titanium Femoral Components made of?

The Vanguard Knee System Titanium Femoral Components are made from titanium alloy, designed for patients with nickel sensitivity to cobalt-chromium alloys.

What is the intended use of the Vanguard Knee System Titanium Femoral Components?

The device is intended for total knee arthroplasty to replace the femoral component of the knee joint in orthopedic surgery.

How are the Vanguard Knee System Titanium Femoral Components supplied?

The device is supplied in ten femoral sizes and is designed for use with bone cement fixation.

Are the Vanguard Knee System Titanium Femoral Components part of a larger system?

Yes, the device is part of the Vanguard Complete Knee System, which offers complete femoral/tibial size interchangeability and two bearing options.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vanguard® Knee System - Zimmer Biomet | Primary Knee Reconstruction ..., Vanguard Knee System Titanium Femoral Components, PDF Vanguard Complete Knee System - Zimmer Biomet, VANGUARD KNEE SYSTEM TITANIUM FEMORAL C... (K080204) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K080204 24 fields · synced Sep 21, 2026