The Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful MTP joint.

Device Description

The Great Toe Implant System is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. It is available in several sizes to accommodate variations in anatomy. Primary fixation is via a press fit.
Materials: The devices are manufactured from CoCrMo alloy per ASTM and ISO standards,
Function: The system functions to provide pain relief and improved function to the first metatarsal joint that has been damaged by inflammatory arthritis.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Great Toe Implant System) seeking FDA clearance. It does not contain specific acceptance criteria, a study proving device performance against such criteria, or any of the detailed information requested in the prompt regarding a clinical study or AI performance evaluation.

The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the United States. This process typically involves comparing the new device's design, materials, manufacturing process, and intended use to a legally marketed predicate device, rather than conducting new clinical studies or establishing detailed performance metrics against acceptance criteria for novel technologies.

Therefore, I cannot provide the requested information from the provided text. The document clearly states:

"There are no significant differences between the Great Toe Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

This indicates that the clearance is based on equivalence, not on the demonstration of specific performance metrics from a new study meeting predefined acceptance criteria.

Summary

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K014164

Summary of Safety and Effectiveness

for

Great Toe Implant System

This safety and effectiveness summary for the Implant System in provided as required por Section 513(1)(3) of the Food, Drug and Cosmetic Act.

1. Submitter :

Harmos Orthopedic Inc. 3238 Player's Club Circle Memphis, TN 38125 901-748-1900

Contact Person :

Richard W. Woods MedCon LLC 1002 Frederick Road Catonsville, MD 21228 ( 410 ) 744-8367 FAX ( 410 ) 744-8368

Date Prepared: December 17, 2001

1. Tradename: Great Toe Implant System Common Name: Great Toe System Classification Name: Prosthesis, Toe, Hemi-, Phalangeal ( 888.3730 )

3. Predicate or legally marketed devices which are substantially equivalent :

. Swanson Titanium Great Toe Implant System ( Dow Corning Wright )
◆ Metallic Hemiarthroplasty Resurfacing Prosthesis ( BioPro )
Futura Biomedical Metal Hemi Toe Implant System (Futura Biomedical ) .

4. Description of the device :

Materials: The devices are manufactured from CoCrMo alloy per ASTM and ISO standards,

Function: The system functions to provide pain relief and improved function to the first metatarsal joint that has been damaged by inflammatory arthritis.

5. Intended Use:

Comparison of the technological characteristics of the device to predicate and legally marketed devices :

There are no significant differences between the Great Toe Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Mr. Richard W. Woods Harmos Orthopedic, Inc. c/o MedCon LLC 1002 Frederick Road Cantonsville, Maryland 21228

Re: K014164

Trade/Device Name: Great Toe Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: December 17. 2001 Received: December 19, 2001

Dear Mr. Woods:

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. Richard Woods

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter will anow you to ough finding of substantial equivalence of your device to a legally premaired 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 If you desire specific acrison. 0 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP are 659. Additionally, for questions on the promotion and advertising of Compliance w (301) 59 - 1 - 1 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 Oiner general inflantacturers, 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,

O. Alark M. Mellever

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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014164

510(k) Number ( if known ) :

Great Toe Implant System Device Name :

Indications For Use :

FM/ADH/005/2003

DEC 15 2:55 PM '03

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

( optional format 1-2-96 )

R. Mark A. Millham
(Division Sign Off)

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

510(k) Number K014164

Page 1 of 1

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.