The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.

Device Description

The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the Variax Clavicle System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-driven device.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided document is a 510(k) summary for a traditional medical device (a bone fixation system) and explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

This device is not an AI/ML device, and its approval relies on demonstrating substantial equivalence to existing predicate devices through non-clinical testing (fatigue strength and pull-off testing) and comparison of technological characteristics.

Summary

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113760

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APR 2 5 2012

510(k) Summary

Sponser:	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person:	Valerie GiambancoRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365
Date Prepared:	April 23, 2012
Proprietary Name:	Variax Clavicle System
Common Name:	Plate. Fixation, Bone
Classification Name	21 CFR § 888.3030: Single/multiple component metallic bonefixation appliances and accessories.
Proposed Regulatory Class:	Class II
Product Codes:	87HRS, 87HWC

Legally marketed device to which substantial equivalence is claimed:

Plate design and Intended Use: Acumed Clavicle Plating System: K112111, Synthes Clavicle Plating System: K101536 and K000684 Materials & Screws: Variax Elbow: K101056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use via K 112455

Device Description:

Indications for Use:

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11 3760

Summary of Technologies:

The technological characteristics (material, design, sizes, and operational principles) of the Variax Clavicle components are similar or identical to its predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Fatigue strength and pull-off testing was conducted. The testing demonstrated that the Variax Clavicle system components met performance requirements and are as safe and effective as their predicate devices.

Clinical Testing:

None provided as a basis for substantial equivalence

Conclusion

The Variax Clavicle System is substantially equivalent to the predicate devices identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Valerie Giambanco Regulatory Affairs Specialist 325 Corporate Drive · Mahwah, New Jersey 07430

APR 2 5 2012

Re: K113760

Trade/Device Name: Variax Clavicle System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 27, 2012 Received: March 28, 2012

Dear Ms. Giambanco:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Valerie Giambanco

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use ·

510(k) Number (if known): _ イリスフ 60

Device Name: Variax Clavicle System

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

Concurrence of CDRH, Office of Device Evaluation (ODE)

NEEDED)

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Dangal

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113760

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.