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Zirconia Articul/Eze Femoral Balls

by Depuy, Inc.

510(k) K952088

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952088 Date30 Jun 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Zirconia Articul/Eze Femoral Balls are orthopedic femoral balls made of Permallon Avant ceramic material. They are available in expanded size ranges including 22.225 mm and 40 mm diameters with neck lengths ranging from -2 to +12, providing surgeons with various biomechanical reconstruction options.

The device is supplied as a single-use implant and is regulated under FDA 510(k) clearance K952088, which was granted on June 30, 1995. It is manufactured by DePuy, Inc. and classified under product code LZO. The device is intended for use in orthopedic applications and should be stored according to the manufacturer's instructions.

Other devices from Depuy, Inc.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Zirconia Articul/Eze Femoral Balls used for?

    Zirconia Articul/Eze Femoral Balls are orthopedic implants made of Permallon Avant ceramic material, designed for various biomechanical reconstruction options in orthopedic applications.

  • What sizes are available for the Zirconia Articul/Eze Femoral Balls?

    These femoral balls are available in expanded size ranges including diameters from 22.225 mm to 40 mm, with neck lengths ranging from -2 to +12, providing surgeons with multiple reconstruction options.

  • Are the Zirconia Articul/Eze Femoral Balls single-use or reusable?

    The Zirconia Articul/Eze Femoral Balls are supplied as single-use implants and should not be reused according to the manufacturer's instructions.

  • What is the regulatory status of these femoral balls?

    The device is regulated under FDA 510(k) clearance K952088, which was granted on June 30, 1995, and is classified under product code LZO.