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Exeter Ceramic Femoral Heads

by Howmedica Osteonics Corp.

510(k) K993889

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K993889↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK993889 Date11 Feb 2000ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The Exeter Ceramic Femoral Heads are a type of Ceramic Femoral Head (Nomenclature Code: LZO), designed for use in total hip arthroplasty. These components are engineered to articulate with acetabular cups, providing a durable and low-friction bearing surface to enhance joint mobility and longevity in hip replacement procedures.

These femoral heads are supplied as single-use, sterile implants intended for surgical implantation by orthopedic surgeons. They are manufactured in compliance with FDA 510(k) clearance (K993889) and EU MDR requirements, ensuring adherence to stringent regulatory standards. Available in standard sizes, they are packaged for intraoperative use and must be handled under aseptic conditions to maintain sterility.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Are the Exeter Ceramic Femoral Heads reusable or designed for single-use only in surgery?

    The Exeter Ceramic Femoral Heads are explicitly designed for single-use only. They are supplied sterile and intended for intraoperative implantation by orthopedic surgeons, requiring aseptic handling to preserve sterility. Reuse is not recommended or supported by the manufacturer.

  • What sizes are available for the Exeter Ceramic Femoral Heads, and how are they packaged for surgery?

    The Exeter Ceramic Femoral Heads are available in standard sizes (specific dimensions are not listed in the data, but these are typically sized to match common femoral stem diameters in total hip arthroplasty). They are packaged for intraoperative use, ensuring sterility and readiness for immediate surgical implantation without additional preparation.

  • How should these femoral heads be stored before use to maintain their sterility?

    The Exeter Ceramic Femoral Heads must be stored under aseptic conditions to preserve their sterility. Since they are single-use implants packaged for surgery, they should remain in their original, unopened packaging until immediately before use. Exposure to contaminants or improper handling could compromise sterility.

  • What regulatory pathways have been followed for the Exeter Ceramic Femoral Heads, and which committees were involved?

    The Exeter Ceramic Femoral Heads were cleared through the FDA 510(k) process (K993889) under the Orthopedic (OR) Advisory Committee, with a decision dated February 11, 2000. They are also compliant with EU MDR requirements, ensuring adherence to both U.S. and European regulatory standards for medical devices.