XTRAFIX EXTERNAL FIXATION SYSTEM

K113383 · Extraortho, Inc. · KTT · Jun 26, 2012 · Orthopedic

Device Facts

• Record ID: K113383
• Device Name: XTRAFIX EXTERNAL FIXATION SYSTEM
• Applicant: Extraortho, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for: Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; Arthrodesis and osteotomies with associated soft tissue problems; Stabilization of limbs after removal of total joint arthroplasty for infection or other failure; Stabilization of non-unions; and Intraoperative temporary stabilization tool to assist with indirect reduction.

Device Story

XtraFix External Fixation System consists of clamps and half pins used to construct external fixation frames. System components are assembled by surgeons to stabilize long bone and pelvic fractures. Device provides mechanical support for bone healing; used in clinical settings for trauma or orthopedic reconstruction. System is MR Conditional, allowing use in magnetic resonance environments under specified conditions. Output is a physical frame construct; aids in fracture reduction and stabilization.

Clinical Evidence

Bench testing only. Evaluated per ASTM F1541-02 (2007) and FDA guidance for orthopedic external fixation devices. MR compatibility testing performed per FDA guidance, establishing the system as MR Conditional.

Technological Characteristics

Metallic bone fixation components (clamps, half pins). Evaluated per ASTM F1541-02 (2007). MR Conditional per FDA guidance for passive implants. No software or electronic components.

Indications for Use

Indicated for patients requiring external fixation for long bone (femur, tibia, foot, humerus) or pelvic fractures, including open/closed fractures, polytrauma, arthrodesis, osteotomies with soft tissue issues, post-arthroplasty limb stabilization, and non-unions.

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

• XtraFix External Fixation System (K091258 and K111155)
• Synthes Large External Fixation Clamps- MR S (K031428)
• Smith & Nephew Jet-X Unilateral Fixator (K994143)

Submission Summary (Full Text)

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JUN 26 2012

# XtraFix External Fixation System Line Additions 510(k) Summary

| Device Manufacturer: | ExtraOrtho, Inc.<br>8275 Tournament Drive, Suite 160<br>Memphis, TN 38125 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | November 16, 2011 |
| Contact Person: | Brian Austin<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | XtraFix External Fixation System Line Additions |
| Common Name: | External Fixation Frame Components |
| Classification regulation: | 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories, 888.3040 Smooth or<br>threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Codes: | KTT and JDW/ Orthopedics/87 |

### Device Description and Intended Use:

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.

The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:

- Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems; o
- Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0

### Predicate Devices:

The XtraFix External Fixation System Line Additions are similar to several predicates including the following:

- XtraFix External Fixation System (K091258 and K111155); .
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KI) 3383

# XtraFix External Fixation System Line Additions 510(k) Summary

- Synthes Large External Fixation Clamps- MR S (K031428); and
- Smith & Nephew Jet-X Unilateral Fixator (K994143).

### Technological Characteristics

The principles of operation of the XtraFix External Fixation System Line Additions are the same as for the predicates. The system was characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. The XtraFix External Fixation System Line Additions were also characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the devices can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document.

#### Substantial Equivalence Information:

The XtraFix External Fixation System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices.

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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

#### Public Health Service

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

## JUN 26 2012

Extraortho, Inc. c/o Marcos Velez-Duran President of MSquared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K113383

Trade/Device Name: XtraFix External Fixator System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: April 6, 2012 Received: April 9, 2012

Dear Mr. Velez-Duran:

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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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/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

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

Enclosure

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K11 33883

# Indications for Use Statement

To be assigned 510(k) Number:

XtraFix External Fixation System Device Name:

Indications for Use: The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system i is intended for:

Stabilization of open or closed fractures, typically in the context of polytrauma or O where open or alternative closed treatment is undesirable or otherwise contraindicated;

- o Arthrodesis and osteotomies with associated soft tissue problems;
- o Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. O

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Autsit

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113383

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