(171 days)
The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.
The Piccolo Composite Distal Femur Plate System comprises implants (plates and screws), 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 screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.
This document describes the Piccolo Composite® Plate System, a medical device for bone fixation. Since this is a 510(k) summary for a medical device and not an AI/software product, the provided text does not contain information about acceptance criteria, study details, or ground truth relevant to AI performance. Therefore, I cannot extract the requested information.
The document discusses the substantial equivalence of the device to predicate devices based on intended use, design, materials, technological characteristics, principles of operation, and performance characteristics as evaluated per ASTM F 382. It does not involve a study of an AI algorithm.
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May 29, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CarboFix Orthopedics Ltd. Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya 46724 Israel
Re: K143496
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: April 27, 2015 Received: April 28, 2015
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. 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
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(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 forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K143496 (page 1/1) 510(K) Number (if known):
Device Name: Piccolo Composite® Plate System
Indications for Use:
The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.
| 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)
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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
December 2014
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).
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Predicate Devices
- Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061)
- 트 Polyax™ Distal Femoral Locked Plating System (DePuy; K060969)
- Synthes 4.5mm VA-LCP Curved Condylar Plate System (Synthes; K083025)
- 트 Synthes LISS DF System (Synthes; K062564)
Indications for Use
The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.
System Description
The Piccolo Composite Distal Femur Plate System comprises implants (plates and screws), 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 screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.
Substantial Equivalence
The Piccolo Composite Distal Femur 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, evaluated per ASTM F 382, are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.