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CFE Total Hip Femoral Component

FDA 510(k)

Class II (US FDA 510(k))

510(k) K830313

by Biomet, Inc.

Identifiers

510(k) Number
K830313 FDA 510(k)
FDA Product Code
JDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3350 FDA 510(k)
Regulation Number
888.3350 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CFE Total Hip Femoral Component is an orthopedic implant used in total hip arthroplasty procedures. It is designed to replace the femoral head and neck portion of the hip joint, providing a prosthetic solution for patients requiring hip replacement surgery.

This device is supplied by Biomet, Inc. and is available in various sizes to accommodate different patient anatomies. The CFE Total Hip Femoral Component has FDA 510(k) clearance with the K830313 product code, indicating it is substantially equivalent to predicate devices for its intended use.

Frequently asked questions

What is the CFE Total Hip Femoral Component used for?

The CFE Total Hip Femoral Component is an orthopedic implant designed to replace the femoral head and neck portion of the hip joint in total hip arthroplasty procedures, providing a prosthetic solution for patients requiring hip replacement surgery.

What sizes and models of the CFE Total Hip Femoral Component are available?

The CFE Total Hip Femoral Component is available in various sizes to accommodate different patient anatomies, though specific size ranges or models are not detailed in the provided information.

What is the regulatory status of the CFE Total Hip Femoral Component?

The CFE Total Hip Femoral Component has FDA 510(k) clearance with the K830313 product code, indicating it is substantially equivalent to predicate devices for its intended use in total hip arthroplasty procedures.

Is the CFE Total Hip Femoral Component supplied sterile?

The device is supplied by Biomet, Inc., but the provided information does not specify whether it is supplied sterile or in non-sterile condition, nor does it indicate if it is for single-use or multiple uses.

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: CFE TOTAL HIP FEMORAL COMPONENT (K830313) - FDA 510 (k), CFE TOTAL HIP FEMORAL COMPONENT 510(k) K830313 - FDA.report, PDF K830313 - Cfe Total Hip Femoral Component, Echo® Hip System - Zimmer Biomet, Mallory/Head Total Hip System; Ha Mallory/Head Total Hip System; Bi ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K830313 24 fields · synced Sep 22, 2026