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 which were previously cleared in K113760. 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. This Special 510(k) submission is intended to introduce 145mm Superior Lateral Plates as a line extension to the currently marketed Superior Lateral Plates in the Variax Clavicle System. This will extend the range of plate sizes from 74mm-145mm in length.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Variax Clavicle System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study that Proves Device Meets Criteria
Material Equivalence	Plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67.	Risk analysis per ISO 14971:2007; comparison to predicate device (K113760).
Design Equivalence	Anatomically contoured Anterior and Superior Lateral Plates, as well as Anterior and Superior Midshaft Plates. Extension of plate size range (74mm-145mm).	Risk analysis per ISO 14971:2007; comparison to predicate device (K113760).
Operational Principle Equivalence	Fixes to the clavicle using 3.5mm or 2.7mm locking or non-locking screws.	Risk analysis per ISO 14971:2007; comparison to predicate device (K113760).
Safety and Effectiveness Equivalence	The new plate length did not present a new worst case. Met performance requirements and are as safe and effective as their predicate devices.	Risk analysis per ISO 14971:2007; "same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate (K113760)".
Intended Use Equivalence	Internal fixation in the clavicle for various fracture types, osteotomies, mal-unions, and non-unions.	Comparison to predicate device (K113760) (stated in Substantial Equivalence section).

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

The provided document does not specify a patient-based "test set" or its sample size, nor data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on an engineering risk analysis and comparison to a predicate device rather than a clinical study with patient data.

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

This information is not applicable as there is no mention of a clinical test set requiring expert ground truth establishment. The evaluation relies on engineering principles and comparison to a predicate.

4. Adjudication Method for the Test Set

This information is not applicable as there is no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate device through non-clinical testing.

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

Not applicable. This device is a bone fixation system, not a software algorithm or AI-powered diagnostic tool. The submission details a medical device, not a digital health product that would have standalone performance.

7. The Type of Ground Truth Used

For this medical device, the "ground truth" is established through engineering principles, material standards (ASTM F136, ASTM F67), risk assessment (ISO 14971:2007), and direct comparison to the design and performance of a previously cleared predicate device (K113760).

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device (bone fixation system), not an AI/ML algorithm that would require a training set.

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

Not applicable. As established in point 8, there is no training set for this type of device.

Summary

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MAR 0 5 2013

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. K130116

510(k) Summary

Variax Clavicle System Proprietary Name: Plate, Fixation, Bone Common Name: Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §

Proposed Regulatory Class:

Product Codes:

HRS: HWC

Variax Clavicle

Class II

Predicate Devices:

Sponsor:

Contact Person:

Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland

888.3030

Estela Celi Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com

January 15,2013

Device Description

Date Prepared:

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Intended Use

The Variax Clavicle System is intended for use in internal fixation in the clavicle.

Indications for Use -

The Variax Clavicle System 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.

Substantial Equivalence

The subject Superior Lateral Plates are substantially equivalent to the Superior Lateral Plates in the Variax Clavicle System cleared under K113760 in regards to intended use, design, materials, and operational principles as a bone fixation device.

Non-Clinical Testing

Risk analysis was performed according to the requirements of ISO 14971:2007 *Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. This evaluation demonstrated that the new plate length did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate (K113760) The analysis demonstrated that the subject Variax Clavicle System plates met performance requirements and are as safe and effective as their predicate devices.

Conclusion

The subject components of the Variax Clavicle System are substantially equivalent to the predicate device identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The symbol features a staff with a snake winding around it, representing healing and medicine.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: March 5, 2013

Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K130116

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: Class II Product Code: HRS, HWC Dated: February 4, 2013 Received: February 5, 2013

Dear Ms. Celi:

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. Ilisting 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 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

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Page 2 - Ms. Estela Celi

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/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosüre

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Indications for Use

510(k) Number (if known): K130116

Device Name: Variax Clavicle System

Prescription Use X AND/OR Over-The-Counter Use (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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.