Estremo Citieffe Nailing System

K181540 · Citieffe S.R.L. · HSB · Jan 16, 2019 · Orthopedic

Device Facts

• Record ID: K181540
• Device Name: Estremo Citieffe Nailing System
• Applicant: Citieffe S.R.L.
• Product Code: HSB · Orthopedic
• Decision Date: Jan 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following: - diaphyseal femoral fractures; - supra-condylar femoral fractures: - corrective osteotomies; - pseudoarthrosis: non-unions and mal-unions. The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following: - diaphyseal tibial fractures; - corrective osteotomies; - pseudoarthrosis; - non-unions and mal-unions. The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

Device Story

Estremo Citieffe Nailing System; intramedullary fixation rod system. Used for stabilization of femoral and tibial fractures and tibiotalocalcaneal arthrodesis. Implanted by orthopedic surgeons in clinical/surgical settings. Provides mechanical support to bone segments to facilitate healing/fusion. System includes rods and associated hardware for fixation. Benefits patient by restoring skeletal alignment and stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary fixation rod system; metallic construction; designed for femoral/tibial fixation and arthrodesis. Class II device (Product Code HSB).

Indications for Use

Indicated for patients requiring femoral or tibial fracture fixation (including diaphyseal, supra-condylar, corrective osteotomies, pseudoarthrosis, non-unions, mal-unions) and tibiotalocalcaneal arthrodesis.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.

CITIEFFE S.r.L. Stefano Pullega Quality and Regulatory Manager Via Armaroli, 21 Calderara di Reno, Bologna 40012 - Italy

Re: K181540

Trade/Device Name: Estremo Citieffe Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 14, 2018 Received: December 17, 2018

Dear Stefano Pullega:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

{1}------------------------------------------------

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K181540

Device Name Estremo Citieffe Nailing System

## Indications for Use (Describe)

The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:

- · diaphyseal femoral fractures;
- · supra-condylar femoral fractures:
- · corrective osteotomies;
- · pseudoarthrosis:
- non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:

- · diaphyseal tibial fractures;
- · corrective osteotomies;
- · pseudoarthrosis;
- · non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."