QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

K100497 · N.M.B. Medical Applications, Ltd. · HSB · Jun 21, 2010 · Orthopedic

Device Facts

• Record ID: K100497
• Device Name: QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
• Applicant: N.M.B. Medical Applications, Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

Device Story

Piccolo Composite Nailing System is an intramedullary fixation device for humeral fractures. Device consists of carbon fiber reinforced polymer cylindrical solid rods (humeral and proximal humerus nails) and titanium-alloy self-tapping interlocking screws. Nails feature closed, pointed distal ends and threaded proximal ends for instrument connection. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures. Surgeon inserts nail into medullary canal and secures with interlocking screws. Provides mechanical stabilization to facilitate bone healing and reconstruction. Benefits include structural support for complex fractures and pathological conditions.

Clinical Evidence

Bench testing only. Biomechanical evaluation demonstrated mechanical properties comparable to predicate devices.

Technological Characteristics

Materials: Carbon fiber reinforced polymer (nail), titanium-alloy (screws). Form factor: Cylindrical solid rod; humeral nail diameter 7-8.5 mm, length 180-280 mm; proximal humerus nail diameter 8 mm (11 mm proximal end), length 150 mm. Principle: Intramedullary fixation via interlocking screws.

Indications for Use

Indicated for patients with humeral fractures, including simple, comminuted, spiral, large oblique, segmental, nonunions, malunions, polytrauma, impending pathological fractures, and post-tumor resection reconstruction. Applicable to fractures between the proximal and distal third of the humerus.

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

• Quantum IM Composite Nailing System (K091425)
• TriGen Straight Humeral Nail System (K032722)
• T2 Nailing System / T2 Proximal Humeral Nail (K032523, K042396, K043404)

Submission Summary (Full Text)

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K100497

N.M.B. Medical Applications Ltd. Piccolo Composite Nailing System

# 510(K) Summary

N.M.B. Medical Applications, Ltd. Piccolo Composite Nailing System (previously named the "Quantum IM Composite Nailing System")

## Applicant Name

BUN 21 2010

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

# Contact Person

Hila Wachsler-Avrahami N.M.B. Medical Applications, Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: [phone], Fax: [phone]

Date Prepared February 2010

### Trade/Proprietary Name

Piccolo Composite Nailing System (previously named the "Quantum IM 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

- 트 Quantum IM Composite Nailing System (N.M.B. Medical Applications, Ltd .; K091425);
- 트 TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722);
- T2 Nailing System / T2 Proximal Humeral Nail (Howmedica Osteonics Corp .; K032523, K042396, K043404);

# Intended Use/Indications for Use

# Piccolo Composite Humeral and Proximal Humerus Nails

Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

## System Description

The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.

The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end 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.

Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA."

JUN 2 1 2010

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

N.M.B. Medical Applications Ltd. % Hila Wachsler-Avrahami 11 Ha'hoshlim Street Herzeliya 46724 Israel

.

Re: K100497

Trade/Device Name: Piccolo Composite Nailing System (previously named the Quantum IM Composite Nailing System)

Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 6, 2010 Received: June 15, 2010

Dear Ms. Wachsler-Avrahami:

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 (reporting of medical

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## Page 2 – Hila Wachsler-Avrahami

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/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buchner

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

Enclosure

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N.M.B. Medical Applications Ltd. Piccolo Composite Nailing System

# Indications for Use

## 510(K) Number (if known): K100497

Device Name: Piccolo Composite Nailing System

(Previously named the "Quantum IM Composite Nailing System")

#### Indications for Use:

#### Piccolo Composite Humeral and Proximal Humerus Nails

Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Smetu for mxm
(Division Sign-Off)

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100497

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