DOLPHIX EXTERNAL FIXATION SYSTEM by CITIEFFE S.R.L.

Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods. Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:

Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
Temporary stabilization of fractures in the context of polytrauma: -
Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
Temporary stabilization of non-unions; -
Intra-operative temporary stabilization tool to assist with indirect reduction. -

Dolphix® External Fixation System is intended for use in a non-weight bearing patient.

Device Description

Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to CITIEFFE s.r.l for their Dolphix® External Fixation System. This document is a regulatory communication concerning the substantial equivalence of a medical device and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, not on specific performance data or clinical study results.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line. The words are clearly legible and appear to be the primary focus of the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2014

CITIEFFE s.r.l % Mr. Claude Berthoin Thema USA 110 East Granada Boulevard, Suite 209 Ormond Beach, Florida 32176

Re: KI32363

Trade/Device Name: Dolphix® External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: December 17, 2013 Received: December 19, 2013

Dear Mr. Berthoin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Claude Berthoin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincercly yours.

Ronald#sJean -S for

Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Applicant: CITIEFFE SRL

510(k) Number (if known): _ K132363

Device Name: Dolphix® External Fixation System

Indication For Use:

Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
Temporary stabilization of fractures in the context of polytrauma: -
Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ infection or other failure;
Temporary stabilization of non-unions; -
Intra-operative temporary stabilization tool to assist with indirect reduction. -

Dolphix® External Fixation System is intended for use in a non-weight bearing patient.

Prescription Use X	And/Or	Over the Counter Use
(21 CFR Part 801 Subpart D)		(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE).

Casey L. Hanley, Ph.D. Division Sign-Off Office of Device Evaluation

510(k)_K132363

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.