PICCOLO COMPOSITE NAILING SYSTEM

K102369 · N.M.B. Medical Applications, Ltd. · HSB · Jan 31, 2011 · Orthopedic

Device Facts

• Record ID: K102369
• Device Name: PICCOLO COMPOSITE NAILING SYSTEM
• Applicant: N.M.B. Medical Applications, Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Jan 31, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Device Story

The Piccolo Composite Nailing System is an intramedullary fixation device for tibia and femur fractures. The system consists of a cannulated, cylindrical nail composed of carbon fiber reinforced polymer, paired with titanium-alloy interlocking screws and specialized insertion/extraction instrumentation. The nail features a pointed distal end and a threaded proximal end for instrument attachment. Used by orthopedic surgeons in a clinical or surgical setting, the device is implanted into the medullary canal to provide structural support and stabilization for bone fractures. The device functions as a mechanical fixation implant; it does not involve electronic processing, software, or AI. Clinical benefit is derived from the stabilization of long bone fractures, facilitating healing and reconstruction.

Clinical Evidence

Bench testing only. Performance characteristics were evaluated per ASTM F 1264, including static 4-point bending, static torsion, and dynamic testing. Testing also supported MR Conditional labeling.

Technological Characteristics

Cannulated, cylindrical intramedullary nail made of carbon fiber reinforced polymer. Tibial nail: 9-11 mm diameter, 260-380 mm length. Femoral nail: 10-12 mm diameter, 300-420 mm length. Includes titanium-alloy interlocking screws. Mechanical fixation principle. Evaluated per ASTM F 1264.

Indications for Use

Indicated for patients requiring fixation of simple, comminuted, spiral, large oblique, or segmental fractures of the tibia and femur; also indicated for nonunions, malunions, polytrauma, prophylactic nailing of impending pathological fractures, and reconstruction following tumor resection/grafting. Applicable to fractures between the proximal and distal third of the long bones.

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 (K091425, K100497)
• Intramedullary Nail (Smith & Nephew, Inc.; K983942, K061019)
• T2 Tibial Nail (Stryker; K003018)
• T2 Femoral Nail (Stryker; K010801)
• UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes; K914453, K962047)
• UFN Unreamed Femoral Nail/CFN Cannulated Femoral Nail (Synthes; K923580, K954856)
• Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, K013449, K032588)

Submission Summary (Full Text)

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Ki02369(1/3)

N.M.B. Medical Applications, Ltd. Piccolo Composite™ Nailing System - Tibia & Femur

# 510(K) Summary

JAN 3 1 2011

## N.M.B. Medical Applications, Ltd.

## Piccolo Composite™ Nailing System - Tibia & Femur

## Applicant Name

N.M.B. Medical Applications, Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel

## Contact Person

Yael Rubin N.M.B. Medical Applications, Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: [phone], Fax: [phone]

## Date Prepared

January 2011

## Trade/Proprietary Name

Piccolo Composite Nailing System

### Common Name

Intramedullary Nailing System

### Classification Name

Rod, Fixation, Intramedullary and Accessories (21 CFR 8888.3020; Product Code HSB)

## Predicate Devices

- Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd .; K091425, . K100497):
- Intramedullary Nail (Smith & Nephew, Inc .; K983942, K061019); 다
- 트 T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more);

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- T2 Femoral Nail (Stryker (Howmedica Osteonics Corp.); K010801 and more).
- 이 UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes: K914453, K962047).
- . UFN Unreamed Femoral Nail/CFN Cannulated Femoral Nail (Synthes: K923580, K954856)
- D Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd .; K002783, K013449, K032588)

## Intended Use/Indications for Use

## Piccolo Composite Tibial and Femoral Nails

Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonumions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

## System Description

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

The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.

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## 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.

N.M.B. Medical Applications Ltd. performed static 4-point bending test, static torsion test, dynamic tests, and testing supporting MR Conditional labeling.

Performance characteristics evaluated per ASTM F 1264 are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use.

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

N.M.B Medical Applications Inc. % Ms. Yael Rubin Director of Regulatory Affairs Ha'hoshlim Street 11 46724 Herzeliva Israel

JAN 3 1 2011

Re: K102369

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: January 25, 2011 Received: January 27, 2011

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Yael Rubin

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/CDRH0ffices/ucm115809.html 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/Resourcesfor You/Industry/default.htm.

Sincerely yours

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

Enclosure

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# Indication for Use

510(K) Number (if known): _ K102369 __________________________________________________________________________________________________________________________________________

Piccolo Composite™ Nailing System Device Name:

## Indication for Use:

Piccolo Composite Tibial and Femoral Nails

Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Melkerm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102369