The Synthes Ankle Arthrodesis Plates are minimally contoured metal plates that utilize traditional internal plate/screw fixation to promote fusion or "arthrodesis" of the ankle.

AI/ML Overview

This document is a 510(k) summary for the Synthes Ankle Arthrodesis Plates. It describes a medical device, its intended use, classification, and a determination of substantial equivalence to a predicate device by the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not a performance study report for a novel AI/software medical device.

Therefore, I cannot provide the requested information in the format specified because the provided text does not contain the details of a study on device performance against acceptance criteria. The document is for a traditional medical device (metal plates) and focuses on regulatory clearance based on substantial equivalence, not on performance metrics of a software or AI algorithm.

Summary

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JUL 2 5 2002

022255
page 1 of 1

3. 510(k) Summary:

510(k) SUMMARY

Submitter:	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact:	Matthew M. Hull(610) 647-9700
Name of the Device:	Synthes (USA) Ankle Arthrodesis Plates
Classification:	Class II, 21 CFR 888.3030
Common or Usual Name:	Plate, Fixation, Bone, Non-spinal
Predicate (unmodified) Device:	Synthes Ankle Arthrodesis Plates, K013415
Device Description:	The Synthes Ankle Arthrodesis Plates are minimallycontoured metal plates that utilize traditional internalplate/screw fixation to promote fusion or "arthrodesis" ofthe ankle.
Intended Use:	The Synthes Ankle Arthrodesis Plates are intended forarthrodesis of the ankle and the distal tibia.
Material:	Stainless Steel

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, suggesting a sense of community and care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD: 20850

JUI 2 5 2002

Mr. Matthew M. Hull. RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road PO Box 1766 Paoli. Pennsylvania 19301

Re: K022255

Trade/Device Name: Synthes Ankle Arthrodesis Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 9. 2002 Received: July 12, 2002

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

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Millenson

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

、

Special 510(k) Device Modification

INTENDED USE STATEMENT

510(k) Number (if known):

K022255

Device Name:

Indications

Synthes Ankle Arthrodesis Plates

The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

(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) Over-the-Counter Use

Mark A. Wilkerson

Recond stime and Neurologi

510(k) Number K022235

Synthes (USA) CONFIDENTIAL Special 510(k): Synthes Ankle Arthrodesis Plates

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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.