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Palabond

by Heraeus Kulzer GmbH & Co. KG 510(k)

Active United States

510(k) K022251

Overview

Palabond is a bone cement used in orthopedic applications. It is a medical device that is designed to be used for surgical procedures involving bone fixation or repair.

The device is supplied as a single-use product and is regulated under FDA 510K clearance with device class 2. It is manufactured by Heraeus Kulzer GmbH & Co. KG in Hanau, Germany, and is not indicated for MRI use. The product code is LOD, and it has been cleared for use in orthopedic procedures.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK022251 Date26 Feb 2003ClearedStatusActive

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
LOD
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is Palabond used for in orthopedic procedures?

    Palabond is a bone cement designed for surgical procedures involving bone fixation or repair. It is specifically formulated to provide stability and support in orthopedic applications where bone cement is required.

  • Is Palabond supplied as a single-use or reusable product?

    Palabond is supplied as a single-use product only. It should not be reused or resterilized after initial use to ensure patient safety and maintain product integrity.

  • What is the regulatory status of Palabond bone cement?

    Palabond is regulated under FDA 510K clearance with device class 2. It has been cleared for use in orthopedic procedures and is manufactured by Heraeus Kulzer GmbH & Co. KG in Hanau, Germany.

  • Is Palabond indicated for MRI use?

    No, Palabond is not indicated for MRI use. The device should not be used in patients undergoing MRI procedures as it may interfere with the imaging process or pose safety risks.