Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia . in children,
Forearm fractures in children and young adolescents, and
Fractures of the humerus in adults. .

Device Description

The Metaizeau™ Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design. The nail is available in five diameters and two lengths.

AI/ML Overview

This document {0} and {1} is a 510(k) summary for the Metaizeau™ Nailing System, an intramedullary nail for temporary stabilization of bone fractures.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria or reported device performance metrics in the way one would typically find for a diagnostic or imaging device.

Instead, the submission is focused on demonstrating substantial equivalence to an existing predicate device. This means the primary "acceptance criterion" for this type of submission is:

Acceptance Criterion: The Metaizeau™ Nailing System must be substantially equivalent to a legally marketed predicate device (an existing intramedullary nailing system) in terms of intended use, design, materials, and operational principles.
Reported Device Performance: The document states, "The supporting information included in following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles."

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical data or patient samples. The substantial equivalence determination for this device likely relies on engineering and material testing, design comparisons, and possibly non-clinical performance data, rather than clinical trial data. Therefore, details about sample size (for a test set of data) and data provenance (country of origin, retrospective/prospective) are not applicable or provided in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this 510(k) summary. "Ground truth" established by experts is typically relevant for diagnostic devices that interpret medical images or signals. For an intramedullary nail, the "ground truth" of its substantial equivalence would be based on engineering principles, material science, and comparison to the predicate device's specifications, all reviewed by regulatory experts within the FDA.

4. Adjudication Method

This information is not applicable as there is no mention of a test set requiring adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted or described in this document. MRMC studies are typically performed for diagnostic or imaging devices to evaluate the performance of human readers with and without AI assistance. This device is a surgical implant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the Metaizeau™ Nailing System is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

As discussed, the concept of "ground truth" in clinical terms (like pathology, expert consensus, or outcomes data) is not relevant for this type of 510(k) submission. The "ground truth" for substantial equivalence is based on:

Comparison of technical specifications: Materials, dimensions, mechanical properties, manufacturing processes.
Intended Use comparison: Showing the new device serves the same purpose as the predicate.
Operational Principles comparison: Demonstrating it functions in a similar manner to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable.

Summary

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510(k) Summary of Safety and Effectiveness Metaizeau™ Nailing System

Proprietary Name:	Metaizeau™ Nailing System
Common Name:	Intramedullary Nail
Classification Name/Reference:	Intramedullary Fixation Rod21 CFR §888.3020
Device Product Code:	87 HSB
Proposed Regulatory Class:	Class II
For Information contact:	Vivian Kelly, Senior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared:	October 20, 2006
DEC 27 2006

Description

Indications

The Metaizeau™ Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to: fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia in children, Forearm fractures in children and young adolescents, and fractures of the humerus in adults.

Substantial Equivalence:

The subject system is substantially equivalent to the predicate nailing system for the stabilization of long bone fractures using a closed technique. The supporting information included in following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles.

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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 features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms. Vivian Kelly Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K063225

Trade/Device Name: Metaizeau™ Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 20, 2006 Received: October 24, 2006

DEC 2 7 2006

Dear Ms. Kelly:

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. 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

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Page 2 - Ms. Vivian Kelly

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 (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ecturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara buchung
for

Mark N. Melkerson 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

510(k) Number (if known):

Device Name: Metaizeau™ Nailing System

Indications for Use:

Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia . in children,
Forearm fractures in children and young adolescents, and �
Fractures of the humerus in adults. .

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Staulaire buchno formsin

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

510(k) Number_KO6 395

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.