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Hoffmann II External Fixation System

by Howmedica Osteonics Corp.

510(k) K000957

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 NumberK000957 Date23 May 2000ClearedStatusActive

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  • Withdrawn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
LXT
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Hoffmann II External Fixation System is a modular external fixation frame used for the treatment of bone fractures. It is designed to allow for the reduction of fractures and the post-operative correction of fragment alignment in three planes while the frame is in situ.

This system is authorized under FDA 510(k) clearance K000957. It is manufactured by Howmedica Osteonics Corp. and is classified as a metal composite appliance for fixation.

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Questions

AI-generated answers, 21 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 is the primary purpose of the Hoffmann II External Fixation System?

    This system is designed for the treatment of bone fractures. It functions as a modular external fixation frame that allows clinicians to perform fracture reduction and post-operative correction of fragment alignment in three planes while the frame remains in situ.

  • What type of device is the Hoffmann II system?

    The Hoffmann II is classified as a metal composite appliance for fixation. It is a modular system intended to stabilize bone segments during the healing process.

  • Is this device authorized for use?

    Yes, the Hoffmann II External Fixation System is authorized under FDA 510(k) clearance K000957, which was granted to Howmedica Osteonics Corp. on May 23, 2000.