This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Distal Fibula Plate are intended to add a different type of plate to the Stryker® Plating System portfolio.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (VariAx™ Distal Fibula Plate), not a study report for an AI/ML powered device. As such, the information requested in the prompt (acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

The document mainly focuses on establishing substantial equivalence to previously marketed devices based on intended use, design, materials, and operational principles, rather than performance metrics from a clinical study using specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

Summary

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510(k) Summary of Safety and Effectiveness VariAx™ Distal Fibula Plate

Proprietary Name:	VariAx ™ Distal Fibula PlateJUL 18 2008
Common Name:	Bone plates and screws
Classification Name/Reference:	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Device Product Code:	87 KTT
Proposed Regulatory Class:	Class II
For Information contact:	Andrea Dwyer, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6250 Fax: (201) 831-6038
Date Summary Prepared:	May 5, 2008

Description:

Indications:

The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.

Substantial Equivalence:

The VariAx™ Distal Fibula Plate is substantially equivalent to the Stryker® Foot, Profyle®, Universal Distal Radius System, and the Synthes® Small Fragment Locking Compression Plate (LCP) System in regards to intended use, design, materials, and operational principles as a fracture plating system.

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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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms. Andrea Dwyer Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430

JUL 1 8 2008

Re: K081284 Trade/Device Name: VariAx™M Distal Fibula Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation Appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 5, 2008 Received: May 6, 2008

Dear Ms. Dwyer:

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 promotions 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 (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.

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Page 2 - Ms. Andrea Dwyer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark M. Milliman

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): YD81284

Device Name: VariAx™ Distal Fibula Plate

Indications for Use:

The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.

Over-The-Counter Use Prescription Use X 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)

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Seubone Buchanan Jr. npxu
Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number K081284

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.