VARIAX CLAVICLE HOOK PLATE

K140259 · Stryker Trauma AG · HRS · Apr 1, 2014 · Orthopedic

Device Facts

• Record ID: K140259
• Device Name: VARIAX CLAVICLE HOOK PLATE
• Applicant: Stryker Trauma AG
• Product Code: HRS · Orthopedic
• Decision Date: Apr 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

Device Story

VariAx Clavicle Hook Plate is a line extension to the VariAx Clavicle System; designed for internal fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and acromioclavicular joint dislocations. Device consists of anatomically contoured plates fixed to bone using 3.5mm locking or non-locking screws. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments; promotes healing through rigid fixation. Output is mechanical stabilization of the clavicle.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including Finite Element Analysis (FEA) and fatigue testing.

Technological Characteristics

Plates manufactured from Titanium Alloy (ASTM F136); screw holes utilize Commercially Pure Titanium (ASTM F67). System uses 3.5mm locking or non-locking screws. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients requiring internal fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and acromioclavicular joint dislocations.

Regulatory Classification

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.

Predicate Devices

• VariAx Clavicle System (K113760)
• VariAx Clavicle System (K130116)
• AAP AcroPlate (K030909)
• Synthes (USA) Clavicle Hook Plates (K061753)

Submission Summary (Full Text)

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#### 510(k) Summary

## Proprietary Name:

Common Name:

Classification Name and Reference:

VariAx Clavicle Hook Plate

Plate, Fixation, Bone

Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030

Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040

Device Class:

Product Code(s):

Sponsor:

For Information Contact:

Class II

HRS & HWC

Stryker Trauma AG

Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

Date Prepared:

January 31, 2014

## Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a line extension to the VariAx Clavicle System, which was previously cleared in VariAx Clavicle System (K113760 & K130116). The VariAx Clavicle System consists of anatomically contoured. Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The subject plates are fixed to the clavicle using 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056 and K132502. This 510(k) submission is intended to introduce Hook Plates to the currently marketed VariAx Clavicle System. The plates are manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes).

# APR 0 1 2014

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## Intended Use

Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

## Indications for Use

Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

## Substantial Equivalence

The subject VariAx Clavicle Hook Plate is substantially equivalent to the VariAx Clavicle System (K113760 & K130116), AAP AcroPlate (K030909) and Synthes (USA) Clavicle Hook Plates (K061753) in regards to intended use, design, materials, and operational principles for use for use in internal fixation in the clavicle.

## Non-Clinical Testing

Non-clinical laboratory testing was performed for the VariAx Clavicle Hook Plate components to determine substantial equivalent. Testing demonstrated that the VariAx Clavicle Plate System is substantially equivalent to the predicate devices. A Finite Element Analysis (FEA) was conducted on the subject VariAx Clavicle Hook Plate in order to assess the worst case plate for performance verification testing. In addition to this, fatigue testing was also conducted to compare the fatigue properties of the subject plates to the predicate AAP AcroPlate. The aim of the testing was to demonstrate substantial equivalence between the subject VariAx Clavicle Hook plate and the predicate AAP AcroPlate.

## Clinical Testing

Clinical testing was not required for this submission.

## Conclusion

The subject components of the VariAx Clavicle Hook Plate are substantially equivalent to the predicate devices identified throughout this submission.

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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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The logo is black and white.

Public Health Service

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

April 1, 2014

Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K140259

Trade/Device Name: VariAx Clavicle Hook Plate 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 12, 2014 Received: February 14, 2014

Dear Mr. Wreh:

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 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 - Mr. Elijah N. Wreh

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

## Lori A. Wiggins

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

Enclosure

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#### Indications for Use

K140259 510(k) Number (if Known):

Device Name: VariAx Clavicle Hook Plate

Indicated for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

. Over-The-Counter Use

(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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