SYNTHES ANKLE ARTHRODESIS PLATE

K013415 · Synthes (Usa) · HRS · Jan 11, 2002 · Orthopedic

Device Facts

• Record ID: K013415
• Device Name: SYNTHES ANKLE ARTHRODESIS PLATE
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle joint and distal tibia.

Device Story

The Synthes Ankle Arthrodesis Plate is a minimally contoured metal plate designed for internal fixation of the ankle and distal tibia. It is used by orthopedic surgeons in a clinical or surgical setting to promote bone fusion (arthrodesis). The device utilizes traditional plate and screw fixation techniques to stabilize the bone, facilitating the fusion process. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a minimally contoured plate constructed from stainless steel. It functions as a single/multiple component metallic bone fixation appliance (Product Code: HRS) under 21 CFR 888.3030.

Indications for Use

Indicated for patients requiring arthrodesis of the ankle joint and distal tibia.

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.

Submission Summary (Full Text)

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K013415
page 1 of 1

#### Summary of Safety and Effectiveness Information 3.

## JAN 11 2002

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 | JAN 11 2002 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 | |
| Name of the Device | Synthes Ankle Arthrodesis Plate | |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone | |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Ankle<br>Arthrodesis Plate to be substantially equivalent to another legally<br>marketed device. | |
| Device Description | The Synthes Ankle Arthrodesis Plate is a minimally contoured metal<br>plate that utilizes traditional internal plate/screw fixation to promote<br>fusion or “arthrodesis” of the ankle. | |
| Indications | The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the<br>ankle and the distal tibia. | |
| Materials | Stainless Steel | |

CONFIDENTIAL

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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 with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 1 2002

Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K013415

Trade/Device Name: Synthes Ankle Arthrodesis Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 12, 2001 Received: October 15, 2001

Dear Mr. Hull:

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 - Mr. Matthew M. Hull, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rhodes
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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#### Indications for Use Statement 2.

510(k) Number (if known):

Device Name:

Indications for Use:

# KOI 3415

Synthes Ankle Arthrodesis Plate

The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle joint and distal tibia.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Stytk Pluorlu

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KU13415 510(k) Number -

Synthes(USA) Synthes Ankle Arthrodesis Plate 510(k) CONFIDENTIAL