SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM

K130044 · Wrightmedicaltechnologyinc · KTT · Apr 5, 2013 · Orthopedic

Device Facts

• Record ID: K130044
• Device Name: SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KTT · Orthopedic
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis Comminuted trauma Diabetic Charcot reconstruction Most foot pathology not requiring fixation above the ankle

Device Story

SIDEKICK® EZ FRAME™ External Fixation System is a mechanical orthopedic device used for bone stabilization in the foot. It utilizes a series of pins and wires to provide compression or distraction, with a boot component to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. It is intended for use by surgeons in clinical settings to treat foot pathologies, including trauma and reconstruction. The device functions as a mechanical support structure; it does not involve electronic inputs, software, or automated processing. By stabilizing bone segments, it facilitates healing and correction of foot deformities.

Clinical Evidence

No clinical data. Substantial equivalence is based on mechanical component analysis and design comparison.

Technological Characteristics

Metallic external fixation system consisting of pins, wires, and a boot. Adjustable design for anatomical variation. Mechanical operation only; no energy source, software, or connectivity. Compatible with SIDEKICK® FREEDOM components.

Indications for Use

Indicated for patients requiring foot fixation for triple arthrodesis, isolated rearfoot arthrodesis, midfoot arthrodesis, comminuted trauma, or diabetic Charcot reconstruction, excluding pathologies requiring fixation above the ankle.

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

• E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT (K043289)

Reference Devices

• SIDEKICK® FREEDOM External Fixation System (K043289)

Submission Summary (Full Text)

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### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## APR 0 5 2013

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SIDEKICK® EZ FRAME™ External Fixation System.

| (a)(1). Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Road<br>Arlington, TN 38002 |
|------------------------------------|-------------------------------------------------------------------------------|
| Date: | January 4, 2013 |
| Contact Person: | Ryan Bormann<br>Regulatory Affairs Specialist II<br>[phone] |
| (a)(2). Proprietary Name: | SIDEKICK® EZ FRAME™ External Fixation<br>System |
| Common Name: | External Fixation Device |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | KTT, Appliance, Fixation, Nail/Blade/Plate<br>Combination, Multiple Component |
| (a)(3). Predicate Device: | K043289 E-Z FRAME EXTERNAL SURGICAL<br>SUPPORT BOOT |

## (a)(4). Device Description

The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAME™ External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.

## (a)(5). INTENDED USE

- · Triple arthrodesis
- · Isolated rearfoot arthrodesis
- · Midfoot arthrodesis
- · Comminuted trauma
- · Diabetic Charcot reconstruction
- · Most foot pathology not requiring fixation above the ankle

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## (a)(6). Technological Characteristics Comparison

The subject device operates in the same method as the predicate.

## (b)(1). Substantial Equivalence – Non-Clinical Evidence ·

- Through mechanical component analysis and comparison the subject system does not represent a new worst-case.
## (b)(2). Substantial Equivalence - Clinical Evidence

N/A

#### (b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: April 5, 2013

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

Wright Medical Technology, Inc. % Mr. Ryan Bormann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K130044

Trade/Device Name: SIDEKICK® EZ FRAME™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT, HTY, JEC Dated: January 4, 2013 Received: January 8, 2013

Dear Mr. Bormann:

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

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#### Page 2 - Mr. Ryan Bormann

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 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 [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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## Indications for Use

## 510(k) Number (if known): K130044

Device Name: SIDEKICK® EZ FRAME™ External Fixation System

Indications For Use:

- Triple arthrodesis .
- lsolated rearfoot arthrodesis .
- Midfoot arthrodesis
- . Comminuted trauma
- . Diabetic Charcot reconstruction
- Most foot pathology not requiring fixation above the ankle .

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Casey LTHanley Division Devices

Concurrence of CDRH, Office of Device Evaluation (ODE) 1 of 1