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Ceramic Femoral Head

by Dow Corning Wright 510(k)

Active United States

510(k) K920593

Overview

The Ceramic Femoral Head is a prosthesis component used in hip arthroplasty procedures. It is classified as a semi-constrained hip prosthesis made of metal/ceramic/polymer materials, designed for either cemented or non-cemented implantation.

This device is supplied in various sizes including a 28mm long modification and is regulated under FDA 510(k) clearance with product code LZO. It is a Class II device under special controls, manufactured by Dow Corning Wright and intended for use in hip replacement surgeries.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920593 Date31 Aug 1992ClearedStatusActive

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
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Ceramic Femoral Head used for?

    The Ceramic Femoral Head is a prosthesis component used in hip arthroplasty procedures. It is classified as a semi-constrained hip prosthesis made of metal/ceramic/polymer materials, designed for either cemented or non-cemented implantation in hip replacement surgeries.

  • What sizes are available for the Ceramic Femoral Head?

    The Ceramic Femoral Head is supplied in various sizes, including a 28mm long modification. These different size options allow for proper fit and function in patients with different anatomical requirements during hip replacement procedures.

  • What is the regulatory status of the Ceramic Femoral Head?

    The Ceramic Femoral Head is regulated under FDA 510(k) clearance with product code LZO. It is classified as a Class II device under special controls, with a decision code of SESE (Substantially Equivalent), and was cleared on 1992-08-31.

  • How is the Ceramic Femoral Head implanted?

    The Ceramic Femoral Head is designed for either cemented or non-cemented implantation methods. This flexibility allows surgeons to choose the most appropriate fixation technique based on the patient's bone quality and specific surgical requirements.