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Afghan External Fixator

by Smith & Nephew, Inc.

510(k) K092002

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 NumberK092002 Date10 Dec 2009ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 19 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 Afghan External Fixator is a unilateral external fixation system designed for stabilizing small bone fractures and bone fragments in non-long bones, such as the patella and olecranon. It falls under the category of orthopedic external fixation devices, providing mechanical support to maintain proper alignment during the healing process.

This device is supplied as a reusable system comprising stainless steel male and female struts, nuts, and frame components. It is intended for use in adolescents (ages 12–21) and adults, with regulatory clearance under the FDA’s 510(k) pathway as a substantially equivalent device. Sterility and MRI safety are not specified in the available data.

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Questions

AI-generated answers, 19 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 types of fractures is the Afghan External Fixator specifically designed to stabilize, and who is it intended for?

    The Afghan External Fixator is designed to stabilize small bone fractures and bone fragments in non-long bones, such as the patella (kneecap) and olecranon (elbow). It is intended for use in adolescents aged 12–21 and adults, providing mechanical support to maintain proper alignment during the healing process.

  • Is the Afghan External Fixator reusable or single-use, and what materials is it made from?

    The Afghan External Fixator is supplied as a reusable system and is constructed from stainless steel, including male and female struts, nuts, and frame components. This design allows for repeated use in clinical settings.

  • How is the Afghan External Fixator regulated in the U.S., and what pathway was used for its clearance?

    The Afghan External Fixator received FDA clearance through the 510(k) pathway, specifically under the Traditional review process. It was determined to be substantially equivalent to a predicate device and falls under the Orthopedic (OR) advisory committee category, with product code KTT.

  • Are there any specific storage requirements mentioned for the Afghan External Fixator?

    The available data does not specify any particular storage requirements for the Afghan External Fixator, such as temperature, humidity, or handling instructions. Since it is reusable and made of stainless steel, standard orthopedic equipment cleaning and maintenance protocols should apply.