Piccolo Composite Nailing System

K173652 · CarboFix Orthopedics , Ltd. · HSB · Dec 28, 2017 · Orthopedic

Device Facts

• Record ID: K173652
• Device Name: Piccolo Composite Nailing System
• Applicant: CarboFix Orthopedics , Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 28, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

Device Story

Intramedullary nailing system for proximal femur fracture fixation; consists of carbon fiber reinforced polymer (CFRP) nails, titanium alloy screws, and surgical instruments. Nails feature cylindrical geometry (11mm mid-shaft, up to 17mm proximal diameter) with lengths 180-460mm. Tantalum markers embedded in CFRP enable radiographic visualization. Used by orthopedic surgeons in clinical/OR settings to stabilize fractures via internal fixation. Device provides mechanical support to bone segments during healing. Benefits include radiolucency of CFRP material and structural stability comparable to metallic predicate systems.

Clinical Evidence

Bench testing only. Performance characteristics evaluated via static and dynamic bending tests of implant constructs. Bacterial endotoxin testing performed. No clinical data provided.

Technological Characteristics

Materials: Carbon fiber reinforced polymer (CFRP), titanium/titanium alloy, tantalum markers. Design: Cylindrical intramedullary rod with proximal/distal interlocking screw holes. Dimensions: 11mm mid-shaft diameter, 180-460mm lengths. Principle: Mechanical internal fixation. Sterilization: Not specified.

Indications for Use

Indicated for patients with stable or unstable proximal femur fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures. Applicable for trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

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.

Predicate Devices

• Piccolo Composite® Proximal Femur Nailing System (K153536, K151010)
• Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

December 28, 2017

CarboFix Orthopedics Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, Israel 4672411

Re: K173652

Trade/Device Name: Piccolo Composite® Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 26, 2017 Received: November 28, 2017

Dear Yael Rubin:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173652

Device Name Piccolo Composite® Nailing System

Indications for Use (Describe)

Piccolo Composite Proximal Femur Nails

The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) Summary

# CarboFix Orthopedics Ltd.

# Piccolo Composite® Proximal Femur Nailing System

# Applicant Name

CarboFix Orthopedics Ltd.

11 Ha'hoshlim St., Herzeliya 4672411, Israel

# Contact Person

Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: [phone], Fax: [phone]

# Date Prepared

December 2017

# Trade/Proprietary Name

Piccolo Composite® Nailing System

# Common Name

Intramedullary Nailing System

# Classification Name

Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB).

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# Predicate Devices

# Primary Predicate:

- Piccolo Composite® Proximal Femur Nailing System (CarboFix Orthopedics Ltd.; K153536, K151010)
Additional Predicate:

- Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and ■ more)
# Intended Use/Indications for Use

The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

# System Description

The Piccolo Composite Nailing System includes nails, screws and a set of instruments.

The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails (and, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.

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# Substantial Equivalence

The Piccolo Composite Proximal Femur Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.

Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of implants construct, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use.

In addition, bacterial endotoxin testing was conducted.