PICCOLO COMPOSITE PLATE SYSTEM

K130061 · CarboFix Orthopedics , Ltd. · HRS · Feb 27, 2013 · Orthopedic

Device Facts

• Record ID: K130061
• Device Name: PICCOLO COMPOSITE PLATE SYSTEM
• Applicant: CarboFix Orthopedics , Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

Device Story

Piccolo Composite Plate System is an orthopedic bone fixation system consisting of plates and screws. Plates are manufactured from carbon fiber reinforced polyetheretherketone (CFR-PEEK) with tantalum thread markers for fluoroscopic visualization. Screws are titanium alloy (locking and nonlocking). System is used by surgeons in clinical settings for internal fixation of long bone fractures, osteotomies, and nonunions/malunions. Device provides mechanical stabilization of bone segments to facilitate healing. Performance is verified via static and dynamic 4-point bending tests.

Clinical Evidence

Bench testing only. Performance evaluated via single cycle (static) and dynamic (fatigue) 4-point bending tests per ASTM F 382. Results demonstrate mechanical characteristics comparable to predicate devices.

Technological Characteristics

Plates: Carbon fiber reinforced polyetheretherketone (CFR-PEEK) with tantalum markers. Screws: Titanium alloy. Dimensions: 4.5mm-5.3mm thickness, 14.5mm-17.5mm width, 82-220mm length. Mechanical testing per ASTM F 382. Non-electronic, mechanical fixation device.

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia) in adults, including osteopenic bone, osteotomies, nonunions, and malunions. Also indicated for diaphyseal fracture fixation in pediatric patients.

Regulatory Classification

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.

Predicate Devices

• Piccolo Composite® Plate System (K102597, K120409)
• Synthes Locking Compression Plate System (K000682, K082807)

Submission Summary (Full Text)

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# 510(K) Summary

CarboFix Orthopedics Ltd.

Piccolo Composite® Plate System

# Applicant Name

CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel

#### Contact Person

Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: [phone], Fax: [phone]

# Date Prepared

January 2013

# Trade/Proprietary Name

Piccolo Composite® Plate System

# Common Name

Plating System

# Classification Name

Single/multiple component metallic bone fixation appliances and accessories (21 CFR §888.3030; Product Code HRS) Smooth or threaded metallic bone fixation fastener (21 CFR §888.3040; Product Code HWC)

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### Predicate Devices

- Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.); K102597, ■ K120409)
- l Members of the Synthes Locking Compression Plate System (Synthes; e.g., K000682, K082807)

# Intended Use/Indications for Use

#### Piccolo Composite Plate System - Diaphyseal

The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.

These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

#### System Description

The Piccolo Composite Plate System comprises implants (plates and screws), and a set of instruments.

The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy.

The Piccolo Composite Diaphyseal Plate is either 4.5mm, or 5.3mm thick; 14.5mm or 17.5mm wide; and is provided in lengths of 82 - 220mm (4 - 13 holes), depending on plates thickness and width.

The screws are made of titanium alloy. Both locking (04.0mm and Ø5.0mm) and nonlocking (04.5mm) screws are available in a range of lengths.

#### Substantial Equivalence

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

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Performance characteristics for the Piccolo Composite Diaphyseal Plate System, such as single cycle (static) 4-point bending and dynamic (fatigue) 4-point bending, were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates and are comparable to those of predicate devices (where applicable). Selected screws characteristics evaluation was also performed. All the above demonstrate that the device is safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus symbol, representing health and medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.

#### Public Health Service

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

February 27, 2013

Carbofix Orthopedics, Ltd. % Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'Hoshlim Street 46724 Herzeliya Israel

Re: K130061

Trade/Device Name: Piccolo Composite® Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: HRS, HWC Dated: January 27, 2013 Received: January 31, 2013

# Dear Ms. 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

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#### Page 2 - Ms. Yael Rubin

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/4/Picture/7 description: The image shows the name "Erin I.D. Keith" in a stylized font. The letters "I.D." are surrounded by concentric lines, giving them a unique design. The overall image has a clean and professional appearance.

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

K130061 510(K) Number (if known):

Device Name: Piccolo Composite® Plate System

Indications for Use:

Piccolo Composite® Plate System - Diaphyseal

The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.

These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth LiFrank -S

Division of Orthopedic Devices