EBA2 FEMORAL NAILING SYSTEM

K131005 · Citieffe S.R.L. · HSB · Jun 25, 2013 · Orthopedic

Device Facts

• Record ID: K131005
• Device Name: EBA2 FEMORAL NAILING SYSTEM
• Applicant: Citieffe S.R.L.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Device Story

EBA2 Femoral Nailing System is an intramedullary fixation rod designed for surgical implantation into the femoral medullary canal. Used by orthopedic surgeons in an operating room setting to treat femoral fractures, deformities, and related pathologies. Device provides mechanical stabilization and alignment of bone segments to facilitate healing. System consists of metallic nails and associated hardware components. Clinical benefit derived from restoring structural integrity of the femur, enabling patient mobilization and bone union.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Intramedullary fixation rod system. Metallic construction. Designed for insertion into the femoral medullary canal for bone stabilization. Class II device under 21 CFR 888.3020.

Indications for Use

Indicated for patients requiring alignment, stabilization, and fixation of femoral fractures or deformities caused by trauma or disease, including fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures, and impending pathological fractures.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

### June 25, 2013

Citieffe S.r.l. % Thema U.S.A Mr. Claude Berthoin Regulatory Consultant 110 East Granada Boulevard, Suite 209 Ormond Beach, Florida 32176

Re: K131005

Trade/Device Name: EBA2 Femoral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 30, 2013 Received: May 31, 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

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## Page 2 - Mr. Claude Berthoin

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] 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" (21CFR 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/ReportaProblem/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

rin I.Keith

For

Mark 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

K131005 510(k) Number (if known): _

Device Name: EBA2 Femoral Nailing System

Indication For Use:

EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (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).

Division Sign-Off Office of Device Evaluation

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

510(k)