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Letournel Acetabular Plate

by Pfizer Inc. 510(k)

Active United States

510(k) K850401

Overview

The Letournel Acetabular Plate is a bone fixation device classified as a Plate, Fixation, Bone, designed for internal fixation of acetabular fractures. It provides structural support to stabilize fractured pelvic bone segments, facilitating proper alignment and healing during orthopedic surgical procedures.

This device is supplied as a reusable surgical implant and is intended for use in orthopedic settings under sterile conditions. It is regulated under FDA 510(k) clearance (K850401) and falls under the HRS classification for bone fixation plates and orthopedic hardware. No additional sterility or MRI safety specifications are noted in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850401 Date19 Apr 1985ClearedStatusActive

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
HRS
FDA applicant
Pfizer, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of acetabular fractures is the Letournel Acetabular Plate designed to stabilize during surgery?

    The Letournel Acetabular Plate is specifically designed for internal fixation of acetabular fractures, providing structural support to stabilize fractured pelvic bone segments. It helps facilitate proper alignment and healing during orthopedic surgical procedures, ensuring the acetabulum remains correctly positioned for recovery.

  • Is the Letournel Acetabular Plate intended for single-use or reusable applications in the operating room?

    The Letournel Acetabular Plate is supplied as a reusable surgical implant, meaning it is intended to be used multiple times after proper cleaning and sterilization between procedures. This makes it cost-effective for orthopedic settings where multiple cases may be performed.

  • How is the Letournel Acetabular Plate regulated, and what does this mean for its use in clinical settings?

    The Letournel Acetabular Plate is regulated under the FDA’s 510(k) clearance process (K850401) and is classified under the HRS product code for bone fixation plates and orthopedic hardware. This means it has been determined to be substantially equivalent to a legally marketed device already on the market, allowing it to be used in clinical settings with the same safety and performance expectations as its predecessor.

  • What considerations should be taken into account when storing the Letournel Acetabular Plate before use?

    Since the Letournel Acetabular Plate is intended for use under sterile conditions, it should be stored in a clean, dry environment to prevent contamination. While no specific sterility specifications are mentioned beyond its surgical use, proper handling and storage protocols—such as avoiding exposure to moisture or sharp objects—are essential to maintain its integrity for reuse in subsequent procedures.