INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM by OSTEOMED CORP.

Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

Device Description

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only.

The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

AI/ML Overview

The provided document is a 510(k) summary and FDA clearance letter for a medical device, the OsteoMed Interphalangeal Flexible Stabilizing Rod System. This type of document is generally used for demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics as might be found for a novel device requiring clinical trials.

Therefore, this document does not contain the information requested in the prompt regarding:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant." It also notes: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues."

This indicates that the clearance was based on substantial equivalence to an already legally marketed device, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria as would be required for a device for which no predicate exists or for a higher-risk classification device. The FDA letter confirms the substantial equivalence determination.

Summary

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NOV 2 6 2002

K022887
page lotl

510(k) Summary

Device Proprietary Name:	OsteoMed InterphalangealFlexible Stabilizing Rod System
Device Common Name:	Toe Implants, Silicone
Classification Name:	Prosthesis, Toe Joint,Constrained, Polymer
Name of Submitter:	OsteoMed Corporation3750 Realty RoadAddison, Texas 75001Phone: (972) 241-3401Fax: (972) 241-3449
Contact Person:	Dawn T. Holdeman
Date Prepared:	August 23, 2002

Summary:

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant.

Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues.

Image /page/0/Picture/11 description: The image shows the logo for Osteomed Corporation. The text "OSTEOMED" is in large, bold, sans-serif font. Below that, in a smaller font, is the word "CORPORATION". The logo is black and white.

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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 stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2002

Ms. Dawn T. Holdeman Regulatory Affairs / Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311

Re: K022887

Trade/Device Name: Interphalangeal Flexible Stabilizing Rod System Regulation Numbers: 21 CFR 888.3720 Regulation Names: Toe joint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: August 29, 2002 Received: August 30, 2002

Dear Ms. Holdeman:

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

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Page 2 – Ms. Dawn T. Holdeman

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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 vours,

Mark A. Mulberson

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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OsteoMed "Indications for Use" Submission

510(k) Number:	K022887
Device Name:	OsteoMed Interphalangeal Flexible Stabilizing Rod System
Indication for Use:	Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)

for Mark A. Milkersm
(Division

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K022887

Regulation Number and Section

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.