Piccolo Composite(R) Distal Volar Radius Plate System

K160002 · CarboFix Orthopedics , Ltd. · HRS · Mar 9, 2016 · Orthopedic

Device Facts

• Record ID: K160002
• Device Name: Piccolo Composite(R) Distal Volar Radius Plate System
• Applicant: CarboFix Orthopedics , Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 9, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.

Device Story

System comprises carbon fiber reinforced polyetheretherketone (CFR-PEEK) plates and titanium alloy screws/pegs; used for distal volar radius fractures and osteotomies. Plates feature tantalum thread for fluoroscopic visualization. Device implanted by orthopedic surgeons in clinical/OR settings to provide bone fixation. Output is mechanical stabilization of bone segments; aids healing by maintaining alignment. Benefits include radiolucency of CFR-PEEK material compared to traditional metal plates, facilitating post-operative imaging.

Clinical Evidence

Bench testing only. Performance characteristics evaluated via mechanical testing, specifically bending of construct per ASTM F 382, to demonstrate equivalence to predicate devices.

Technological Characteristics

Plates: Carbon fiber reinforced polyetheretherketone (CFR-PEEK) with tantalum thread for radiopacity. Screws/pegs: Titanium alloy. Plate thickness: 2.4mm. Lengths: 54-72mm (3-5 holes). Mechanical testing performed per ASTM F 382.

Indications for Use

Indicated for patients requiring fixation for fractures and osteotomies of the distal volar radius.

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, K130061)
• Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate (K083694)

Submission Summary (Full Text)

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

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

March 9, 2016

Re: K160002 Trade/Device Name: Piccolo Composite® Distal Volar Radius 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, KTT Dated: February 4, 2016 Received: February 8, 2016

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 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

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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 Industry and Consumer Education at its toll-free 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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

510(k) Number (if known) K160002

#### Device Name

Piccolo Composite® Distal Volar Radius Plate System

Indications for Use (Describe)

The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) Summary

# CarboFix Orthopedics Ltd.

# Piccolo Composite® Distal Volar Radius Plate System

#### Applicant Name

CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel

#### Contact Person

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

### Date Prepared

February 3, 2016

# Trade/Proprietary Name

Piccolo Composite® Distal Volar Radius Plate System

# Common Name

Bone Plating System

### Classification Name

Single/multiple component metallic bone fixation appliances and accessories (21 CFR §888.3030; Product Code HRS, KTT)

#### Predicate Devices

- 트 Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061)

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- Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate (Synthes; K083694)
#### Intended Use/Indications for Use

The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.

#### System Description

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

The "triangular" plates, added in this 510(k) Notification, are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy, like the rest of the Piccolo Composite plates.

The "triangular" Piccolo Composite distal volar radius plate is 2.4mm thick. The plate shaft comprises 3 - 5 holes, corresponding to plate lengths in the range of 54 - 72 mm. The screws and pegs are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs, in various dimensions.

### Substantial Equivalence

The Piccolo Composite Distal Volar Radius Plate 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 Distal Volar Radius Plate System components included bending of construct, evaluated per ASTM F 382, and are comparable to those of predicate devices (as applicable) thus demonstrating that the device is safe and effective for its intended use.