VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM

K141204 · Stryker Trauma AG · HRS · Jun 20, 2014 · Orthopedic

Device Facts

• Record ID: K141204
• Device Name: VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
• Applicant: Stryker Trauma AG
• Product Code: HRS · Orthopedic
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.

Device Story

Internal bone fixation system consisting of straight plates and compatible screws; used for stabilization of fractures, osteotomies, and non-unions in various skeletal sites including clavicle, scapula, humerus, radius, ulna, pelvis, and foot/ankle bones. Device implanted by orthopedic surgeons in clinical/surgical settings. Provides mechanical support to bone segments to facilitate healing; intended for use in patients with normal or osteopenic bone density. Available sterile in lengths 23-191mm.

Clinical Evidence

No clinical data. Bench testing only, including 4-point bending and 4-point bending construct out-of-plane testing.

Technological Characteristics

Metallic bone fixation plates and screws. Dimensions range from 23-191mm. Sterile. Mechanical fixation principle.

Indications for Use

Indicated for adult patients requiring internal fixation of fractures, osteotomies, or non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, and small bones in the ankle, fore, mid- and hind foot. Applicable for normal bone density and osteopenic bone.

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

• Stryker Foot Plating System (K063875)
• Synthes One-Third Tubular Plate (K011335)

Submission Summary (Full Text)

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K141204 Page 1 of 2

#### 510(k) Summary

Proprietary Name:

VariAx 2 One-Third Tubular Plating System

Common Name:

Bone plates

**Classification Name and Reference:**

Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR \$888.3030

Regulatory Class:

Class II

Product Codes:

Sponsor:

Contact Person:

Switzerland Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

87 HRS: Plate, Fixation, Bone

Stryker Trauma AG

Bohnackerweg 1 CH-2545 Selzach

Phone: [phone] Fax: [phone] [e-mail]

Date Prepared:

May 7, 2014

#### Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 One-Third Tubular Plating System. The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.

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#### Intended Use

The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.

#### Indications

The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.

Indications include the following:

- · osteotomies and non-unions
- · fixation of fractures
- · normal bone density and osteopenic bone

#### Summary of Technologies

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices:

- K063875 Stryker Foot Plating System .
- K011335 Synthes One-Third Tubular Plate .

#### Non-Clinical Testing

Non-clinical laboratory testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.

The following testing was performed

- 4-Point Bending Out of Plane Testing .
- . 4-Point Bending Construct Out of Plane Testing

#### Clinical Testing

Clinical testing was not required for this submission.

#### Conclusion

The VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

June 20, 2014

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

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

Re: K141204

Trade/Device Name: VariAx 2 One-Third Tubular Plating 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 Dated: May 7, 2014 Received: May 9, 2014

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, 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 - 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 contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Mark N. Melkerson -A

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141204

Device Name

VariAx 2 One-Third Tubular Plating System

#### Indications for Use (Describe)

The Stryker VariAx 2 One-Third Tubular Plating System is internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.

Indications include the following:

- · osteotomies, and non-unions
- · fixation of fractures
- · normal bone density and osteopenic bone

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

.

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabet同办公Frank -S

Division of Orthopedic Devices

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