SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM by SYNTHES (USA)

The Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0mm guide wire is used with the system.

AI/ML Overview

My apologies, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Synthes Titanium Cannulated Humeral Nail System), which primarily focuses on establishing substantial equivalence to a legally marketed predicate device.

Specifically, the document states: "Documentation is provided which demonstrated the Synthes Titanium Cannulated Humeral Nail System to be substantially equivalent to other legally marketed devices." This indicates that the regulatory pathway chosen was based on comparing the new device to existing ones rather than presenting performance data against pre-defined acceptance criteria from a specific study.

Therefore, I cannot provide the requested information, as it is not present in the given text.

Summary

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NOV - 5 2003

03307/
page 1 of 1

3. Summary of Safety and Effectiveness Information [510(k) Summary]

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Lisa M. Boyle(610) 647-9700
Name of the Device	Synthes Titanium Cannulated Humeral Nail System
Device Classification(s)	Class II, §888.3020 - Intramedullary Fixation Rod
Device Description	The Synthes Titanium Cannulated Humeral Nail System consists ofcannulated titanium intramedullary rods, and end caps in a variety ofsizes designed for treatment of various humeral fractures. A 2.0mmguide wire is used with the system.
Indications	The Synthes Titanium Cannulated Humeral Nail System is intended toaid in the alignment and stabilization of humeral fractures to include:Diaphyseal fractures of the humeral shaft Fractures of the proximal humerus Proximal humeral fractures with diaphyseal extension Impending pathologic fractures Malunions and nonunions
Substantial Equivalence	Documentation is provided which demonstrated the Synthes TitaniumCannulated Humeral Nail System to be substantially equivalent toother legally marketed devices.The term "substantial equivalence" as used in this 510(k) notificationis limited to the definition of substantial equivalence found in theFederal Food, Drug and Cosmetic Act, as amended and as appliedunder 21CFR 807, Subpart E under which a device can be marketedwithout premarket approval or reclassification. A determination ofsubstantial equivalency under this notification is not intended to haveany bearing whatsoever on the resolution of patent infringement suitsor any other patent matters. No statements related to, or in support ofsubstantial equivalence herein shall be construed as an admissionagainst interest under the US Patent Laws or their application by thecourts.
Material	Titanium Alloy

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K033071

Trade/Device Name: Synthes (USA) Titanium Cannulated Humeral Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: September 26, 2003 Received: September 29, 2003

Dear Ms. Boyle:

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 such 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); 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.

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Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

K03307/

Synthes (USA) Titanium Cannulated Humeral Nail System

The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:

Diaphyseal fractures of the humeral shaft ●
Fractures of the proximal humerus ●
. Proximal humeral fractures with diaphyseal extension
. Impending pathologic fractures
Malunions and nonunions .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Mark A. Mulhern

Division Sign-Off) (Division of General, Restorative Divisiourological Devices

10(k) Number -

Synthes(USA)

Regulation Number and Section

§ 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.