PICCOLO COMPOSITE PLATE SYSTEM

K120409 · CarboFix Orthopedics , Ltd. · HRS · Nov 26, 2012 · Orthopedic

Device Facts

Record IDK120409
Device NamePICCOLO COMPOSITE PLATE SYSTEM
ApplicantCarboFix Orthopedics , Ltd.
Product CodeHRS · Orthopedic
Decision DateNov 26, 2012
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

Piccolo Composite™ Distal Fibula Plate System The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone. Piccolo Composite™ One-Third Tubular Plate System The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone. Piccolo Composite™ Proximal Humerus Plate System 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 System The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.

Device Story

Bone plating system comprising carbon fiber reinforced polyetheretherketone (CFR-PEEK) plates and titanium alloy screws; includes surgical instruments. Plates feature tantalum thread for fluoroscopic visualization. Used by surgeons in clinical settings for internal fixation of bone fractures, osteotomies, and non-unions. Provides mechanical stabilization of bone segments to facilitate healing. Output is physical structural support; no digital or algorithmic output. Device is MR conditional.

Clinical Evidence

Bench testing only. Performance evaluated via single cycle (static) and dynamic (fatigue) 4-point bending tests per ASTM F 382. Additional testing included axial static and dynamic bending, screw characteristics evaluation, and MR conditional labeling support.

Technological Characteristics

Plates: Carbon fiber reinforced polyetheretherketone (CFR-PEEK) with tantalum thread for radiopacity. Screws: Titanium alloy. Mechanical testing per ASTM F 382. Non-locking and locking screw options. MR conditional.

Indications for Use

Indicated for fractures, osteotomies, non-unions, and fracture dislocations of the distal fibula, clavicle, scapula, radius, ulna, pelvis, and proximal humerus, including in patients with osteopenic bone.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ page 1 of 3 ﺎﺕ Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular # 510(K) Summary ### CarboFix Orthopedics Ltd. Piccolo Composite™ Plate System # Applicant Name CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel #### Contact Person Yael Rubin CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St:, Herzeliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939 ### Date Prepared April 2012 # 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, KTT). NOV 2 6 2012 {1}------------------------------------------------ Page 2 of 3 Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular #### Predicate Devices 1 - Piccolo Composite™ Plate System (CarboFix Orthopedics Ltd.; K102597) 트 - 포 Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates (Synthes; K073460) - I Synthes One Third Tubular LCP Plate (Synthes; K011335) - D VariAx™ Distal Fibula Plate and Fibula Straight Plates (Stryker (Howmedica Osteonics Corp.); K081284) - . SPS Small Fragment Set (Stryker (Howmedica Osteonics Corp.); K000636) - I Mini Variable System (OrthoHelix Surgical Designs, Inc .; K111041) #### Indications for Use # Piccolo Composite™ Distal Fibula Plate System The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone. # Piccolo Composite™ One-Third Tubular Plate System The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone. # Piccolo Composite™ Proximal Humerus Plate System 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 System The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius. #### System Description The Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems comprise implants (plates and screws), and sets of instruments. {2}------------------------------------------------ page 3 of 3 Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular 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 Screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions. The general description of the Piccolo Composite™ Proximal Humerus and Distal Volar Radius Plate Systems is not changed as compared to the predicates. #### 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. Performance characteristics for the Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems, 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 and are comparable to those of predicate devices (where applicable). Axial static and dynamic bending tests, selected screws characteristics evaluation, and evaluation in support of the MR Conditional labeling parameters were also provided. All the above demonstrate that the device is safe and effective for its intended use. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 November 26, 2012 CarboFix Orthopedics, Limited % Mr. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, Israel 46724 Re: K120409 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: Class II Product Code: HRS, KTT Dated: November 20, 2012 Received: November 23, 2012 Dear Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {4}------------------------------------------------ Page 2- Mr. 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/CDRHVCDRHOffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Erin I. Keith Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and . Radiological Health Enclosure {5}------------------------------------------------ 510(K) Number (if known): __ Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular # Indications for Use 170406 Piccolo Composite™ Plate System Device Name: #### Indications for Use: Piccolo Composite™ Distal Fibula Piate System The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone. # Piccolo Composite™ One-Third Tubular Plate System The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone. ### Piccolo Composite™ Proximal Humerus Plate System 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 System The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius. Prescription Use _____________ V (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR . (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) Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.11.26 12:46:22 -05'00'
Innolitics
510(k) Summary
Decision Summary
Classification Order
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