XTRAFIX EXTERNAL FIXATION SYSTEM

K111155 · Extraortho, Inc. · KTT · Oct 20, 2011 · Orthopedic

Device Facts

• Record ID: K111155
• Device Name: XTRAFIX EXTERNAL FIXATION SYSTEM
• Applicant: Extraortho, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Oct 20, 2011
• 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 (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for: Temporary stabilization of open or closed acute fractures with soft tissue injuries; Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated; Stabilization of fractures in the context of polytrauma; Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; Arthrodesis and osteotomies with associated soft tissue problems; Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure; Neutralization of fractures stabilized with limited internal fixation; Stabilization of non-unions; and Intraoperative temporary stabilization tool to assist with indirect reduction.

Device Story

System comprises modular components: clamps, posts, bars, fixation pins; used to construct external fixation frames. Operates as mechanical stabilization device for orthopedic fractures; applied by surgeons in clinical/OR settings. Provides rigid support to bone segments; facilitates fracture healing or stabilization during/after surgery. MR Conditional status allows use in MR environment under specified conditions. Benefits include stabilization of complex fractures, polytrauma, and non-unions where internal fixation is contraindicated or insufficient.

Clinical Evidence

Bench testing only; no clinical data presented. Device evaluated for MR safety and compatibility per FDA guidance.

Technological Characteristics

Metallic bone fixation system consisting of clamps, posts, bars, and pins. Passive implant. MR Conditional. Mechanical assembly.

Indications for Use

Indicated for patients requiring external fixation for long bone (foot, femur, tibia) and pelvic fractures, including acute fractures with soft tissue injury, polytrauma, non-unions, arthrodesis, osteotomies, and post-arthroplasty stabilization.

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

• ExtraOrtho XtraFix External Fixation System (K091258)
• Stryker Hoffmann II MRI External Fixation System (K053472)
• Synthes Large External Fixation Clamps- MR S (K082650)
• Smith & Nephew Jet-X Unilateral Fixator (K072212)

Submission Summary (Full Text)

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## XtraFix External Fixation System K11155 510(k) Summary

| Device Manufacturer: | ExtraOrtho, Inc.<br>8275 Tournament Drive, Suite 160<br>Memphis, TN 38125 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | October 20, 2011 |
| Contact Person: | Steve Miller<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | XtraFix External Fixation System |
| 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 system includes clamps, posts, bars, and fixation pins.

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

- Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
- . Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma; .
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; .
- Arthrodesis and osteotomies with associated soft tissue problems; .
- Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation; .
- . Stabilization of non-unions; and
- . Intraoperative temporary stabilization tool to assist with indirect reduction.

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# XtraFix External Fixation System K11155 510(k) Summary

#### Predicate Devices:

The XtraFix External Fixation System is similar to several predicates including the following:

- ExtraOrtho XtraFix External Fixation System (K091258); .
- Stryker Hoffmann II MRI External Fixation System (K053472); .
- . Synthes Large External Fixation Clamps- MR S (K082650); and
- Smith & Nephew Jet-X Unilateral Fixator (K072212). .

#### Technological Characteristics

The principles of operation of the XtraFix External Fixation System are the same as for the predicates. The XtraFix External Fixation System was 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 device 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Extraortho, Inc. % Mr. Marcos Velez-Duran 901 King Street, Suite 200 Alexandria, Virginia 22314

OCT 2 0 2011

Re: K111155

Trade/Device Name: XtraFix Extrnal Fixation 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: September 29, 2011 Received: September 30, 2011

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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### Page 2 - Mr. Marcos Velez-Duran

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.

Erinl Kett

- 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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## Indications for Use Statement

To be assigned KIIII55 510(k) Number:

Xtrafix External Fixation System Device Name:

Indications for Use: The Xtrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

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

- Temporary stabilization of open or closed acute fractures with soft tissue injuries; O
- Definitive stabilization of open or closed fractures where open or alternative closed 0 treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma; O
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; ೧
- Arthrodesis and osteotomies with associated soft tissue problems; O
- Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for 0 infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation; 0
- Stabilization of non-unions; and O
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0

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)

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

510(k) Number

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