The Synthes High Tibial Osteotomy Plate is intended for closing wedge high tibial osteotomies for treatment of bone and joint deformities and misalignment caused by injury or disease such as osteoarthritis.

Device Description

The Synthes High Tibial Osteotomy Plate is a flat, triangle shaped metal plate, that works as a tension band utilizing traditional internal plate/screw fixation.

AI/ML Overview

This document is a 510(k) premarket notification for the "Synthes High Tibial Osteotomy Plate," a medical device used for bone fixation. The provided text does not include any information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

Device Identification: Name, classification, and contact information.
Substantial Equivalence: The primary basis for clearance, stating that it's substantially equivalent to a legally marketed predicate device. This means the FDA found it to be as safe and effective as a device already on the market, without requiring new clinical trials to prove its performance against specific acceptance criteria.
Device Description: A brief explanation of its form and function.
Indications for Use: The specific medical conditions and procedures for which the device is intended.
Material: Stainless Steel.
FDA Communication: The letter from the FDA confirming the 510(k) clearance based on substantial equivalence and outlining regulatory responsibilities.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as none of this information is present in the provided text.

Summary

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MAR 2 1 2002

K014197

page 1 of 1

Summary of Safety and Effectiveness Information 3.

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes High Tibial Osteotomy Plate
Device Classification(s)	Class II, §888.3030 -- Plate, Fixation, Bone
Substantial Equivalence	Documentation was provided which demonstrated the Synthes HighTibial Osteotomy Plate to be substantially equivalent to another legallymarketed device.
Device Description	The Synthes High Tibial Osteotomy Plate is a flat, triangle shapedmetal plate, that works as a tension band utilizing traditional internalplate/screw fixation.
Indications	The Synthes High Tibial Osteotomy Plate is intended for closingwedge high tibial osteotomies for treatment of bone and jointdeformities and misalignment caused by injury or disease such asosteoarthritis.
Material	Stainless Steel

CONFIDENTIAL Synthes(USA) Synthes High Tibial Osteotomy Plate 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

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

Re: K014197

Trade/Device Name: Synthes High Tibial Osteotomy Plate Regulation Number: 21 CFR §888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: December 19, 2001 Received: December 21, 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 Hull

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to ough finding of substantial equivalence of your device to a legally prematice notification: "The starsification 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of adultionally 21 21 1 1 1 1 1 1 1 - 659. Additionally, for questions on the promotion and advertising of Compinates were contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

Sincerely yours,

Mark N. Mulkern

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:

长014197

Synthes High Tibial Osteotomy Plate

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

Madk A Millersa

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

510(k) Number -

CONFIDENTIAL Synthes(USA) Synthes High Tibial Osteotomy Plate 510(k)

000004

Regulation Number and Section

N/A