MODIFICATION TO EBI XFIX DFS SYSTEM

K024129 · Ebi, L.P. · KTT · Jan 15, 2003 · Orthopedic

Device Facts

• Record ID: K024129
• Device Name: MODIFICATION TO EBI XFIX DFS SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Jan 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® XFIX® DFS® System is 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

External fixation system consisting of bone screws and fixator frame; bone screws inserted through skin/soft tissue into bone; fixator frame attached to screw shanks to stabilize bone. Used by surgeons in clinical settings for orthopedic procedures. Addition of XS Gradual Swivel Clamp allows for adjustment. Device provides mechanical stabilization to facilitate bone healing or correction.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

External fixation system; components made of aluminum, stainless steel, and titanium alloy. Non-sterile. Mechanical fixation via bone screws and clamps. No software or electronic components.

Indications for Use

Indicated for patients requiring external fixation for bone conditions including leg lengthening, osteotomies, arthrodesis, and fracture 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)
• EBI® XFIX® DFS® System (K000319)

Submission Summary (Full Text)

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JAN 1 5 2003

K024/29
page 1 of 2

## 510(k) Summary

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

- 1. Sponsor: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa Telephone: [phone],ext.2208

Date prepared: December 13, 2002

| 2. Proprietary Name: | EBI® XFIX® DFS® System |
|-----------------------|----------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Device |
| Classification Names: | Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories, 21 CFR<br>888.3030 |

- 3. Predicate or Legally Marketed Device:
- EBI® XFIX® DFS® System -- EBI, L.P. (K953406) ●
- EBI® XFIX® DFS® System EBI, L.P. (K000319) .

### 4. Description of the device:

The System consists of external fixation components 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. The fixator frame of the EBI XFIX DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a XS Gradual Swivel Clamp to the System.

### 5. Intended Use:

The EBI® XFIX® DFS® System is 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.

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024129
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#### 6. Materials:

The components of the System may be manufactured from materials such as aluminum, stainless steel, and titanium alloy.

## 7. Comparison of the technological characteristics of the device to predicate devices:

The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:

EBI XFIX DFS System (K953406)

- The modified EBI XFIX DFS System is fabricated from the same materials as the components of the currently marketed EBI XFIX DFS Fixation System.
- The modified EBI XFIX DFS System and the currently marketed EBI ● XFIX DFS System are both indicated for 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.
- . The bone screw clamps of the modified EBI XFIX DFS System, like the bone screw clamps currently marketed in the EBI XFIX DFS System, are designed for attachment to the bone screws.
- . The additional component of the EBI XFIX DFS System, like the components of the currently marketed EBI XFIX DFS System, is provided non-sterile.
- . There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent* to the predicate device with regard 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 approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, with the silhouette of a human profile incorporated into the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 5 2003

Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K024129

Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 13, 2002 Received: December 16, 2002

Dear Mr Testa:

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.

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. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact 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 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N. Millherson

Celia 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 1

510(k) Number (if known):

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***_*****_ OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
for
(Division Sign-)
Division of Gerend, Restorative
and Neurological Devices
510(k) Number**K024129