PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM

K123810 · CarboFix Orthopedics , Ltd. · HSB · Jun 14, 2013 · Orthopedic

Device Facts

• Record ID: K123810
• Device Name: PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
• Applicant: CarboFix Orthopedics , Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (malunited tibial pilon fracture) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

Device Story

Piccolo Composite Ankle Arthrodesis Nailing System consists of cannulated, cylindrical nails and interlocking screws; used for tibiotalocalcaneal arthrodesis. Device implanted by orthopedic surgeons in clinical/surgical settings. Nail composed of carbon fiber reinforced polymer; interlocking screws made of titanium alloy. System provides mechanical stabilization of ankle joint to facilitate fusion. Performance evaluated via bending and torsion testing per ASTM F 1264. MR Conditional labeling provided.

Clinical Evidence

Bench testing only. Performance characteristics including bending and torsion parameters were evaluated per ASTM F 1264. MR Conditional labeling parameters were also assessed.

Technological Characteristics

Cannulated, cylindrical intramedullary nail; carbon fiber reinforced polymer construction; titanium-alloy interlocking screws. Nail diameter 10mm-12mm; length 160mm-240mm. Mechanical fixation via interlocking screws. Evaluated per ASTM F 1264.

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis (fusion) due to conditions including avascular necrosis of the talus, failed total ankle arthroplasty, trauma, severe deformity/instability (e.g., talipes equinovarus, paralysis, neuromuscular disease), revision arthrodesis, neuroarthropathy, arthritis (rheumatoid, osteoarthritis, post-traumatic, endstage degenerative), pseudoarthrosis, previously infected arthrosis, Charcot foot, or severe defects after tumor resection.

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 Nailing System - Tibia and Femur (K102369, K111056)
• Phoenix Ankle Arthrodesis Nailing System (K081243, K091976)
• Valor® Ankle Fusion Nail System (K090857)

Submission Summary (Full Text)

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K123810

# 510(K) Summary

# JUN 1 4 2013

# CarboFix Orthopedics Ltd.

# Piccolo Composite® Nailing System - Ankle Arthrodesis

# 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

May 2013

# 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)

### Predicate Devices

- Piccolo Composite Nailing System - Tibia and Femur (CarboFix Orthopedics Ltd .; K102369, K111056)

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#### K123810

### CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis

- Phoenix Ankle Arthrodesis Nailing System (Biomet Trauma; K081243, K091976)
- Valor® Ankle Fusion Nail System (Wright Medical Technology, Inc .; K090857)

# Intended Use/Indications for Use

Piccolo Composite Ankle Arthrodesis Nails

The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

- 1. Avascular necrosis of the talus
- 2. Failed total ankle arthroplasty
- 3. Trauma (malunited tibial pilon fracture)
- 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- 5. Revision ankle arthrodesis
- 6. Neuroarthropathy
- 7. Rheumatoid arthritis
- 8. Osteoarthritis
- 9. Pseudoarthrosis
- 10. Post-traumatic arthrosis
- 11. Previously infected arthrosis
- 12. Charcot foot
- 13. Severe endstage degenerative arthritis
- l 4. Severe defects after tumor resection
- 15. Pantalar arthrodesis

### System Description

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

The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths

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### CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis

in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.

K123810

### 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.

Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. Evaluation in support of MR Conditional labeling parameters was also provided. All the above demonstrate that the device is safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lea th Service

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

June 14, 2013

CarboFix Orthopedics Limited % Ms. Yael Rubin Director of Regulatory Alfairs 11 Ha'hoshlim Street Herzeliya 46724 Israel

Re: K123810

Trade/Device Name: Piccolo Composite™ Nailing System Regulation Nur iber: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 12, 2013 Received: May 14, 2013

Dear Ms. Rubin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above ard 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 Amend:nents, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and-Gosmetic-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. Pleas : note: CDRH docs not evaluate information related to contract liability warranties. We rer ind you; however that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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); lateling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 – Ms. Yael Rubin

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 301), 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 CDKH's Office of Surveillance and 3iometrics/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.

For

Sincerely yours.

Erin |. Keith

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

Enclosure

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# Indication for Use

510(K) Number (if known):

Piccolo Composite® Nailing System Device Name:

# Indication for Use:

Piccolo Composite Ankle Arthrodesis Nails

The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

- 1. Avascular necrosis of the talus
- 2. Failed total ankle arthroplasty
- 3. Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular 4. accident, paralysis or other neuromuscular disease
- 5. Revision ankle arthrodesis
- 6. Neuroarthropathy
- 7. Rheumatoid arthritis
- Osteoarthritis 8.
- 9. Pseudoarthrosis
- 10. Post-traumatic arthrosis
- 11. Previously infected arthrosis
- 12. Charcot foot
- 13. Severe endstage degenerative arthritis
- 14. Severe defects after tumor resection
- 15 .- Pantalar-arthrodesis

Prescription Use

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices