VARIAX 2 SYSTEM

K140769 · Stryker Trauma AG · HRS · Apr 17, 2014 · Orthopedic

Device Facts

• Record ID: K140769
• Device Name: VARIAX 2 SYSTEM
• Applicant: Stryker Trauma AG
• Product Code: HRS · Orthopedic
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.

Device Story

VariAx 2 System comprises metallic bone screws and instrumentation for internal bone fixation. Used in conjunction with previously cleared VariAx Plating Systems or independently via lag screw technique. Operates as mechanical fixation hardware to stabilize bone fractures, osteotomies, or revision sites. Used by orthopedic surgeons in clinical/surgical settings. Provides structural support to bone segments to facilitate healing. Available sterile or non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by risk analysis and bench testing demonstrating performance requirements met.

Technological Characteristics

Metallic bone fixation screws and instrumentation. Materials and design consistent with predicate K132502. No software or electronic components.

Indications for Use

Indicated for internal fracture fixation, osteotomies, and revision procedures (non-unions/mal-unions) in adult patients. Specific screw sizes (T8 2.4mm/2.0mm, T8 2.7mm, T10 3.5mm/2.7mm) are indicated for small bones, distal radius, foot, ankle, ulna, clavicle, humerus, distal tibia, and fibula for treatment of compression, intra-articular, extra-articular, displaced, single, segmental, and comminuted fractures, as well as replantation, joint fusions, arthrodesis, and reconstruction in patients with normal or 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

• VariAx 2 System (K132502)

Submission Summary (Full Text)

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#### 510(k) Summary

| Proprietary Name: | VariAx 2 System | APR 17 2014 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Common Name: | Bone Screws | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and<br>accessories 21 CFR §888.3030 | |
| | Smooth or threaded metallic bone fixation fastener<br>21 CFR §888.3040 | |
| Regulatory Class: | Class II | |
| Product Codes: | HRS: Plate, Fixation, Bone<br>HWC: Screw, Fixation, Bone<br>HTN: Washer, Bolt Nut | |
| Sponsor: | Stryker Trauma AG<br>Bohnackerweg 1<br>CH-2545 Selzach<br>Switzerland | |
| Contact Person: | Elijah N. Wreh<br>Regulatory Affairs Specialist<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared: | March 26, 2014 | |

### Description

This Special 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, ankle, distal tibia and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.

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# Intended Use

ﻨﺔ.

The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.

## Indications

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

- · Internal fracture fixation;
- · Osteotomies;
- · Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

- · T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the
- Distal Radius, in the treatment of:
- o Compression fractures;
- Intra-articular and extra-articular fractures; O
- Displaced fractures: o
- Reconstruction procedures; o
- · T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, o
- Displaced and compression fractures of the Distal Radius: o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; O
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o
- Single, segmental and comminuted fractures; ਼
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. O

## Substantial Equivulencv

The subject device components are substantially equivalent to the previously cleared VariAx 2 System (K 132502) in regards to intended use, materials, and operational principles and similar with regard to design for use in for internal bone fixation in adult patients.

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## Non-Clinical Test

A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices – Application of risk management of medical devices." The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate device (K132502). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices.

## Conclusion

The subject components of the VariAx 2 System are substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person embracing three wavy lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(166-G609 Silver Spring, MD 20993-0002

#### April 17, 2014

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

Re: K140769

Trade/Device Name: VariAx 2 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, HTN Dated: March 26, 2014 Received: March 27, 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. 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 - 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/ReportalProblem/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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K140769 510(k) Number (if known):

Device Name: VariAx 2 System

Indications for Use:

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

- · Internal fracture fixation:
- · Osteotomies:
- · Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

- · T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- Compression fractures; 0
- Intra-articular and extra-articular fractures; 0
- Displaced fractures; 0
- Reconstruction procedures: 0
- · T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; ಂ
- Reconstruction procedures in the Foot & Ankle and Distal Radius; O
- · T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o
- Single, segmental and comminuted fractures; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; 0
- Normal bone density or osteopenic bone. O

Over-The-Counter Use AND/OR Prescription Use _ X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Divison of Orthopedic Devices

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