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Dolphix External Fixation System

by Citieffe s.r.l. 510(k)

Active United States

510(k) K132363

Overview

The Dolphix External Fixation System is a temporary external fixation system indicated for the temporary stabilization of fractures, including complex articular and periarticular fractures of the distal femur, proximal and distal tibia. It is designed for simple, rapid and safe temporary fracture fixation in trauma centers, complex emergencies, and military operations. The system is MR Conditional and is used in Damage Control surgery.

The Dolphix External Fixation System is supplied as a modular orthopedic device and is intended for temporary use. It is authorized under FDA 510(k) clearance with product code KTT and K number K132363. The device is manufactured by Citieffe S.R.L. and is available in various sizes as specified in the system documentation.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132363 Date16 Jan 2014ClearedStatusActive

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
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Dolphix External Fixation System used for?

    The Dolphix External Fixation System is a temporary external fixation system indicated for the temporary stabilization of fractures, including complex articular and periarticular fractures of the distal femur, proximal and distal tibia. It is designed for simple, rapid and safe temporary fracture fixation in trauma centers, complex emergencies, and military operations.

  • How is the Dolphix External Fixation System supplied?

    The Dolphix External Fixation System is supplied as a modular orthopedic device and is intended for temporary use. It is available in various sizes as specified in the system documentation. The device is manufactured by Citieffe S.R.L.

  • What is the regulatory status of the Dolphix External Fixation System?

    The Dolphix External Fixation System is authorized under FDA 510(k) clearance with product code KTT and K number K132363. It received FDA clearance on January 16, 2014, after being submitted on July 30, 2013. The device is MR Conditional and is used in Damage Control surgery.

  • Is the Dolphix External Fixation System reusable?

    The Dolphix External Fixation System is intended for temporary use. While the device itself may be designed for single applications, the system's modularity allows for various configurations depending on the specific fracture stabilization needs. The exact reusability should be determined according to the manufacturer's instructions and clinical guidelines.