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Infinity Porous-Coated Trochanteric Module

by Dow Corning Wright 510(k)

Active United States

510(k) K911595

Overview

The Infinity Porous-Coated Trochanteric Module is a hip prosthesis femoral component made of metal and designed for cemented use. It features a porous coating with a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns.

This device is intended for biological fixation to bone without the use of cement. It is supplied as a single-use device and is not MRI safe. The device is classified under product code JDG and has FDA 510(k) clearance with number K911595, granted on July 12, 1991, for some indications.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK911595 Date12 Jul 1991DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Infinity(Tm) Porous-Coated Trochanteric Module
510(k) Number
FDA Product Code
JDG
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What is the Infinity Porous-Coated Trochanteric Module used for?

    The Infinity Porous-Coated Trochanteric Module is a hip prosthesis femoral component designed for biological fixation to bone without cement. It features a porous coating that promotes bone ingrowth for secure attachment in hip replacement surgeries.

  • How is the Infinity Porous-Coated Trochanteric Module supplied?

    The device is supplied as a single-use device, meaning it is intended for one patient only and should not be reused. It is not MRI safe due to its metal construction.

  • What are the specifications of the porous coating on this device?

    The porous coating has a volume porosity between 30-70%, average pore size between 100-1,000 microns, interconnecting porosity, and coating thickness between 500-1,500 microns, designed to promote biological fixation to bone.

  • What is the regulatory status of the Infinity Porous-Coated Trochanteric Module?

    The device has FDA 510(k) clearance with number K911595, granted on July 12, 1991, for some indications. It is classified under product code JDG and is considered substantially equivalent for certain uses in hip replacement procedures.