The Stealth Fusion System and its accessory components are intended to be used on adults or pediatric patients as required and are intended to be used for ankle and foot joints fusion; to stabilize fractures of foot bones; (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of foot bones; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue foot defects; joint arthrodesis; and management of comminuted intra-articular foot bone fractures.

Device Description

The Stealth Fusion System is an orthopedic device indicated for the use of bone fusion and other bone abnormalities and deformities. As with most external fixation devices, the standard Stealth Fusion System fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Stealth Fusion System design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the lower extremity and immediate range of motion of all adjacent joints.

AI/ML Overview

I am sorry, but the document provided does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for a medical device (Stealth Fusion System), which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Information on experts used to establish ground truth.
Adjudication methods.
Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
Results from standalone performance studies.
Details on the type of ground truth used.
Sample size for training sets.
How ground truth for training sets was established.

The document mainly describes the device, its intended use, technological characteristics, and states its substantial equivalence to predicate devices based on similar design, materials, and intended use. Performance data, if collected, would typically be summarized in a more detailed technical report which is not part of this 510(k) summary.

Summary

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Ko43174

FEB - 7 2005

510(k) SUMMARY OCTOBER 18, 2004

In accordance with the Safe Medical Device Act (SMDA) and in conformance with 21 CFR In accordance with the bare hereby submits this request and accompanying information for 807.07, R&R Mcdical, mo; fierory oach 0(k) documentation. R&R Medical intends to produce If view of our i re market received on the steammercial distribution the Stealth Fusion Fixation System.

SUBMITTER/AUTHORIZED REPRESENTATIVE I. Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, TX 78681 Tele/Fax: 512-388-0199 Ortho.medix@sbcglobal.net
CLASSIFICATION NAME II. Single/multiple component metallic bone fixation appliances and accessories
III. COMMON NAME External Bone Fixation device
DEVICE TRADE NAME IV. Stealth Fusion System

CLASSIFICATION V.

a. Class: Per 21 CFR Sec 888.3030
b. Device Panel Code: Orthopedics/87
c. Device Product Code: KTT, JDW

PREDICATE DEVICES VI.

Ilizarov External Fixation System (Smith-Nephew Richards) a.
b. Orthofix® Modulsystem

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DESCRIPTION VII.

DESCRIPTION
The Stealth Fusion System is an orthopedic device indicated for The Stealth Fusion System is an other bone abnomalities and deformities. As with
the use of bone fusion and other bone aborned fives and deformities. As with the use of bone fusion and other oone addiomants mision System fixator
most external fixation devices, the standard Stealth Fusion anchorage most external fixation devices, the standar seems: 1) bone anchorage
assembly consists of three basic types of elements . The Stealth assembly consists of three basic types of clements. The Stealth Fusion
elements, 2) bridge elements, and 3) connection elements. The Stealth Fusion elements, 2) bridge elements, and 37 colnection ease of assembly and stable
System design allows freedom of pin placement, ease of assembly and stable System design allows freedom of pin pussibility of axial loading of the lower
fixation of bone fragments with the possibility of axial loading of the lower fixation of bothe fragments with are posses
extremity and immediate range of motion of all adjacent joints.

INTENDED USE VIII.

INTENDED USE
The Stealth Fusion System and its accessory components are intended to be used for The Stealth Fusion System and its accessiry over intended to be used for used on adults or pediatric patients as reques of the foot bones; (open and
ankle and foot joints fusion; to stabilize fractures of the foot bones; of range of ankle and toot joints fusion, to staontize nation in the may as a frange of
closed); post-traumatic joint contracture which may sessult in ioint contractures closed); post-traumatic joint contracture which generally in joint contractures
motion; fractures and disease which generally may resultan; pseudoarthrosis motion; fractures and disease wincil generally ing distraction; pseudoarthrosis
or loss of range of motion and fractures requiring distraction; deformity; or loss of range of monon and rractire of bony of soft tissue deformity;
or non-union of foot bones; correction of bony in loster icant arthrodes; or non-union of foot bones, contection of bony of occuses in the orders is and
correction of segmental bony or soft tissue foot defects; joint arthrodesis; and correction of segmentar bony of bon accuration foot bone fractures.

TECHNOLOGICAL CHARACTERISTICS IX.

TECHNOLOGICAL CHARACTEXtBHOD The principle of operation of the Stourn's very similar to the predicate its predicate devices. The included as an external bone fixation system.
devices. That is, it is used as an external multilateral bone used in the devices. That is, it is used as an external multilations of the same or similar to those used in the predicate device.

SUBSTANTIAL EQUIVALENCE INFORMATION X.

SUBSTANTIAL EQUIVALEINCE INCOMMON STATES , like the Uizarov and
The Stealth Fusion System and its accessory components, like the lizzarov and The Stealth Fusion System and its accessed to be used on adults or pediatric
the Orthofix® Modulsystem, is intended to be and foot joints fin the Orthofix& Modulsystem, is intended to be used for ankle and foot joints fusion;
patients as required and is intended to be clicical final fixed fixed from is patients as required and is included to o o asso rical function and design is
to stabilize fractures of the foot bones. The circal function and design is
to stabilize fractur to stabilize fractures of the predicate devices. The fixator pins are very similar to that of the predical grade stainless steel. The external
manufactured from the same medical grade stainless steel. The external manufactured from the same modious grom the same aluminum alloy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

Public Health Service

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R & R Medical, Inc. C/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Received: November 16, 2004

Re: K043174

Trade/Device Name: Stealth Fusion System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT, JDW Dated: October 18, 2004

Dear Mr. J.D. Webb:

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 four over 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. J.D. Webb

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) 276-0120 . 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 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/industry/support/index.html.

Sincerely yours,
Mark A. Wilkerson

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

510(k) number (if known): N

Device Name: Stealth Fusion System

Indications for Use:

PRESCRIPTION

USE X

Mark N. Millen

Restorative, and Neurological

-10(k) Number K043174

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.