Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

Device Description

The VariAx™ Distal Radius Torx Screws in combination with the plates from the Stryker® Leibinger Universal Distal Radius System are designed to treat various types of fractures of the distal radius.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VariAxTM Distal Radius Torx Screws, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical properties comparable to predicate devices	Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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

The provided text does not contain information regarding a specific "test set" in the context of an AI/algorithm-based device. The study described is mechanical testing comparing the new device to predicate devices. Therefore, details like sample size for a test set, data provenance (country of origin, retrospective/prospective) are not applicable or mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable as the described study is mechanical testing of physical implants, not an AI or diagnostic device that requires expert-established ground truth from a test set of medical data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical implant (bone screws and plates) and focuses on mechanical equivalence to existing predicate devices, not on the diagnostic accuracy or effectiveness of an AI system with or without human assistance.

6. If a Standalone (Algorithm Only) Performance Study was done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the mechanical properties of the predicate devices. The new device's performance is compared against these established mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of mechanical testing of a medical implant.

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

This information is not applicable for the same reasons as point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a mechanical testing study. The VariAx™ Distal Radius Torx Screws were subjected to mechanical tests, and their performance was directly compared to the mechanical properties of two predicate devices: the Stryker® Leibinger Universal Distal Radius System and the Stryker® Foot System.

The acceptance criterion was that the new device's mechanical properties should be "comparable" to those of the predicate components. The study concluded that the "Mechanical testing demonstrated comparable mechanical properties to the predicate components," thereby establishing substantial equivalence. This type of equivalence demonstration is common for medical devices that are modifications or iterations of existing, legally marketed devices.

Summary

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K080667

Summary of Safety and Effectiveness VariAxTM Distal Radius Torx Screws

MAR 1 9 2008

Proprietary Name:	VariAxTM Distal Radius Torx Screws
Common Name:	Bone plates and screws
Classification Name andReference:	Single/multiple component metallic bonefixation appliances and accessories, 21 CFR$888.3030
Device Product Code:	87 HRS
For Information Contact:	Danielle Hillman, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365Fax: (201) 831-6038
Date Summary Prepared:	March 7, 2008

Description:

Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available both sterile and non-sterile intended for use in fracture fixation of the distal radius. The indications for use for the VariAx™ Distal Radius Screws are provided below.

Indications for Use:

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Substantial Equivalence:

The subject VariAx™ Distal Radius Screws share the same intended use and design concepts as that of the currently available Stryker® Leibinger Universal Distal Radius System and Stryker® Foot System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.

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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 coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms. Danielle Hillman 325 Corporate Drive Mahwah, NJ 07430

MAR 1 9 2008

K080667 Re: Trade/Device Name: VariAx Distal Radius Torx Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 7, 2008 Received: March 10, 2008

Dear Ms. Hillman:

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 - Ms. Danielle Hillman

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 yours.

Mark M Mulhearn

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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510(k) Number (if known): ≤ 000667

Device Name: VariAxTM Distal Radius Torx Screws

Indications for Use:

Prescription Use Over-The-Counter 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)

Jenita
(Division Sign-Off)
for
Division of General, Restorative,
and Nom

and Neurological Devices

510(k) Number_ 60 8066

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.