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Lateralized Intergral Porous Primary Femoral Component

FDA 510(k)

Class II (US FDA 510(k))

510(k) K984296

by Biomet, Inc.

Identifiers

510(k) Number
K984296 FDA 510(k)
FDA Product Code
LPH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3358 FDA 510(k)
Regulation Number
888.3358 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lateralized Integral Porous Primary Femoral Component is a modular femoral hip prosthesis. It is designed with a 6-mm medial shift of the trunion and taper to increase horizontal offset, which serves to improve joint stability through soft tissue tensioning.

This device is intended for press-fit, single-use implantation. It is authorized under FDA 510(k) clearance K984296.

Frequently asked questions

What is the primary function of this femoral component?

This modular femoral hip prosthesis is designed with a 6-mm medial shift of the trunion and taper. This shift increases the horizontal offset, which helps improve joint stability by facilitating proper soft tissue tensioning.

Is this device intended for multiple uses?

No, this device is strictly for single-use implantation. It is designed to be used once for a specific patient procedure to ensure the integrity of the press-fit fixation.

How is this component implanted?

The component is intended for press-fit implantation. This method relies on the mechanical fit between the porous surface of the implant and the prepared bone to achieve initial stability without the use of bone cement.

What is the regulatory status of this device?

This device is authorized under FDA 510(k) clearance K984296. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: Lateralized Intergral Porous Primary Femoral Component (K984296) — Fda ..., Lateralized Intergral Porous Primary Femoral Component, Echo® Hip System - Zimmer Biomet, Device Listing 1944111078 - FDA.report, K030501 FDA 510(k) - X-SERIES INTEGRAL LATERALIZED HIP COMPO...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K984296 24 fields · synced Sep 21, 2026