VariAx 2 One-Third Tubular Plating System

K151879 · Stryker GmbH · HRS · Aug 6, 2015 · Orthopedic

Device Facts

• Record ID: K151879
• Device Name: VariAx 2 One-Third Tubular Plating System
• Applicant: Stryker GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Special
• 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

VariAx 2 One-Third Tubular Plating System is an internal bone fixation device consisting of metallic plates and compatible screws. Used by surgeons in clinical settings to stabilize fractures, osteotomies, and non-unions in various skeletal locations. Modification from predicate (K141204) includes adjusted plate thickness and added waist grooves to enhance mechanical performance. Plates range from 23-191mm in length; provided sterile or non-sterile. Device functions by providing rigid fixation to bone segments, facilitating healing in patients with normal or osteopenic bone density.

Clinical Evidence

No clinical data; clinical testing was not required for this submission.

Technological Characteristics

Metallic bone fixation plates; dimensions 23-191mm length. Features modified plate thickness and waist grooves for improved mechanical behavior. Risk management per DIN EN ISO 14971. Sterilization provided for sterile components.

Indications for Use

Indicated for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, and small bones in the ankle, fore, mid- and hind foot in adult patients. Includes osteotomies, non-unions, and fixation in 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 One-Third Tubular Plating System (K141204)

Submission Summary (Full Text)

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

August 6, 2015

Stryker GmbH. Dr. Heike Gustke Regulatory Affairs Specialist Prof. - Kuentscher - Str. 1-5 24232 Schoenkirchen, Schleswig-Holstein Germany

Re: K151879

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: July 6, 2015 Received: July 9, 2015

Dear Dr. Gustke:

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

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### Page 2 - Dr. Heike Gustke

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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

#### Indications for Use

510(k) Number (if known)

K151879

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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#### 6 510(k) Summary

| Proprietary Name: | VariAx 2 One-Third Tubular Plating System |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates |
| Regulation Description: | Single/multiple component metallic bone fixation appliances<br>and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS (Plate, Fixation, Bone) |
| Class: | Class II |
| Sponsor: | Stryker GmbH<br>Bohnackerweg 1<br>2545 Selzach / Switzerland |
| Contact Person: | Dr. Heike Gustke<br>Regulatory Affairs Specialist<br>Prof.-Kuentscher-Str. 1-5<br>24232 Schoenkirchen / Germany<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 30, 2015 |

#### Description

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for a device modification of VariAx 2 One-Third Tubular Plates previously cleared in K141204 (VariAx 2 One-Third Tubular Plating System). Modification includes a change of plate thickness and addition of grooves to the waist part of the plate to improve mechanical behavior.

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,

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fore, mid- and hind foot in adult patients. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 23-191mm in length.

### Intended Use

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

### Indications for Use

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 demonstrated that the subject device is substantially equivalent to the previously cleared VariAx 2 One-Third Tubular Plating System (K141204) in regards to intended use, indications for use, material, and operational principles as well as similar in regards to design for internal fixation of bones in adult patients.

#### Non-Clinical Test

A risk analysis was performed according to the requirements of DIN EN ISO 14971 'Medical devices - Application of risk management to medical devices'. Records of risk analysis process are retained in design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject device in comparison to the previously cleared predicate device (K141204). The analyses demonstrated that the subject device met the performance requirements and is as safe and effective as the predicate device.

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## 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 device identified in this premarket notification.