PICCOLO COMPOSITE PLATE SYSTEM

K102597 · N.M.B. Medical Applications, Ltd. · HRS · Feb 24, 2011 · Orthopedic

Device Facts

• Record ID: K102597
• Device Name: PICCOLO COMPOSITE PLATE SYSTEM
• Applicant: N.M.B. Medical Applications, Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Piccolo Composite™ Diaphyseal Plate 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. Piccolo Composite™ Proximal Humerus Plate The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone. Piccolo Composite™ Distal Volar Radius Plate The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.

Device Story

Piccolo Composite™ Plate System consists of carbon fiber reinforced polyetheretherketone (CFR-PEEK) plates and titanium alloy screws/pegs. Plates include tantalum markers for fluoroscopic visualization. System used by surgeons for orthopedic bone fixation. Device provides mechanical stabilization of fractures, osteotomies, and nonunions. Benefits include radiolucency of CFR-PEEK material compared to traditional metallic plates, allowing improved imaging of fracture healing. System is implanted surgically; provides structural support during bone healing process.

Clinical Evidence

Bench testing only. Performance evaluated via static and dynamic 4-point bending tests per ASTM F 382. Results were comparable to predicate devices. MR conditional labeling parameters were supported by testing.

Technological Characteristics

Plates: Carbon fiber reinforced polyetheretherketone (CFR-PEEK) with tantalum thread markers. Screws/pegs: Titanium alloy. Mechanical testing per ASTM F 382. MR conditional.

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia) in adults, including osteopenic bone, osteotomies, nonunions, or malunions; diaphyseal fracture fixation in pediatric patients; proximal humerus fractures, dislocations, osteotomies, and nonunions; and distal volar radius fractures and osteotomies.

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

• Synthes 4.5 mm Locking Compression Plate System (K082807)
• Synthes LCP Proximal Humerus Plate (K011815)
• Synthes LCP Proximal Humerus Plate, Long (K041860)
• DVR Anatomic Plating System (K002775, K090374)

Reference Devices

• Piccolo Composite™ Nailing System (K091425, K100497)
• Fixion® DHS System (K031401)

Submission Summary (Full Text)

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# 510(K) Summary

FEB 2 4 2011

# N.M.B. Medical Applications Ltd. Piccolo Composite™ Plate System

# Applicant Name

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

September 2010

### Trade/Proprietary Name

Piccolo Composite™ Plate System

### Common Name

Bone Plating System

### Classification Name

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

#### Predicate Devices

Intended Use/Design/Technology/Operation

- Synthes 4.5 mm Locking Compression Plate System (Synthes; K082807) ■
- Synthes LCP Proximal Humerus Plate (Synthes; K011815) 트

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- 트 Synthes LCP Proximal Humerus Plate, Long (Synthes; K041860)
- 트 DVR Anatomic Plating System (DePuy Orthopaedics, Inc. (previously Hand Innovations, Inc.); e.g., K002775, K090374)

The above mentioned predicate plates are manufactured from titanium, titanium alloy and/or stainless steel.

#### Material

- Piccolo Composite™ Nailing System (formerly named Quantum IM Composite . Nailing System) (N.M.B. Medical Applications Ltd .; K091425, K100497)
- . Fixion® DHS System (N.M.B. Medical Applications Ltd .; K031401)

The material of the Piccolo Composite Plate (CFR-PEEK) was previously cleared for use in intramedullary rods (K091425, K100497).

#### Intended Use/Indications for Use

# Piccolo Composite™ Diaphyseal Plate

The Piccolo Composite TM 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.

# Piccolo Composite™ Proximal Humerus Plate

The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.

# Piccolo Composite™ Distal Volar Radius Plate

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

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# System Description

The Piccolo Composite Plate System comprises implants (plates and screws/pegs), 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 following types of plates are available:

- ◆ Diaphyseal Plates (thickness: 4.5 mm or 5 mm);
- · Proximal Humerus Plate (thickness: 3.7 mm);
- · Distal Volar Radius Plate (thickness: 2.4 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 (to be used only with the Distal Radius Plate), in various dimensions.

#### Substantial Equivalence

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

The Piccolo Composite Plates are manufactured from the identical CFR-PEEK material as the components cleared in K091425 and K100497.

Performance characteristics of the subject plates, 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. Testing in support of the MR Conditional labeling parameters was also provided. Results were comparable to those of similar predicate devices, thus demonstrating that the system is safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three branches. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.

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

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

FEB 2 4 2011

Re: K102597

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: II Product Codes: HRS, KTT Dated: January 7, 2011 Received: January 10, 2011

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 - Ms. 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 yours,

Sincerely yours,

For

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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# Indications for Use

| 510(K) Number (if known): | K102597 |
|---------------------------|---------|
|---------------------------|---------|

Piccolo Composite™ Plate System Device Name:

# Indications for Use:

# Piccolo Composite™ Diaphyseal Plate

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.

# Piccolo Composite™ Proximal Humerus Plate

The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.

# Piccolo Composite™ Distal Volar Radius Plate

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

Prescription Use AND/OR (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>for M. Melkerson</i> |
|---------------------|-------------------------|
| (Division Sign-Off) | |

Division of Surgical, Orthopedic,
and Restorative Devices

| 510(k) Number | K102597 |
|---------------|---------|
|---------------|---------|