MODIFICATION TO EBI XFIX DFS SYSTEM

K014276 · Ebi, L.P. · KTT · Mar 1, 2002 · Orthopedic

Device Facts

• Record ID: K014276
• Device Name: MODIFICATION TO EBI XFIX DFS SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 1, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Story

The EBI XFIX DFS System is a unilateral external fixation device consisting of metallic bone screws and external fixation components. Bone screws are inserted through skin and soft tissue into bone to provide stabilization. The system is used for orthopedic procedures including leg lengthening, osteotomies, arthrodesis, and fracture fixation. This specific submission covers a labeling change allowing the Standard Fixator to be reused twice, provided the Central Body Component is replaced between each use. The device is intended for prescription use by healthcare professionals in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Unilateral external fixation system. Materials include titanium, stainless steel, and aluminum. Mechanical assembly consisting of bone screws and a central body component. Designed for reuse with specific component replacement protocols.

Indications for Use

Indicated for patients requiring treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, and fracture fixation via external fixation.

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

• EBI® XFIX® DFS® System (K953406)

Submission Summary (Full Text)

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K014276

### 2002 mar 1

# 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

| 1. Submitter: EBI, L.P.<br>100 Interpace Parkway<br>Parsippany, NJ 07054 | Contact Person: Frederic Testa<br>Telephone: [phone] |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Date prepared: December 26, 2001 | |
| 2. Proprietary Name: | EBI® XFIX® DFS® System |
| Common Name: | External Fixation Device |
| Classification Names: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories, 21 CFR 888.3030 |

3. Predicate or legally marketed devices that are substantially equivalent:

- EBI® XFIX® DFS® System EBI, L.P. (K953406) �
- Description of the device. The system consists of external fixation components 4. and implantable bone screws. The EBI® XFIX® DFS® System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. This submission is for a labeling change to reflect that the EBI® XFIX® DFS® Standard Fixator may be reused twice when the Central Body Component is replaced between each reuse.
- 3. Intended Usc: The EBI® XFIX® DFS® System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis,

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014276

fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

- 4. Materials: The components of the System may be manufactured from materials such as titanium, stainless steel, and aluminum.
- 5. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® XFIX® DFS® System and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market ally other product is included only to relate to be interpreted as an admission or any other type of evidence in approval of reclassification and is not linenent Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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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 image of an eagle or bird-like figure with flowing lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAR 1 2002

EBI.

Jon Caparotta, RAC Manager, Regulatory Affairs 7 Studebaker 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K014276

Trade Name: XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: KTT Dated: January 30, 2002 Received: January 31, 2002

Dear Mr. Caparotta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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# Page 2 - Mr. Jon Caparotta

This letter will allow you to begin marketing your device as described in your Section 510(k) This icity with anow your to obgen finding of substantial equivalence of your device to a legally promatic. houried.on: "The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire spoonle advice for for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 007. Additionally, for questions on the promotion and advertising of Compinance at (301) 29 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outcr general manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

Page of looof of loa

510(k) Number (if known):

K014276

Device Name: EBI® XFIX® DFS® System

### Indications For Use:

The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of Gene Il, Restorative and Neurological Devices

510(k) Number K014276