EBI XFIX DFS SYSTEM

K012024 · Ebi, L.P. · KTT · Jul 25, 2001 · Orthopedic

Device Facts

• Record ID: K012024
• Device Name: EBI XFIX DFS SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 25, 2001
• 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

Unilateral external fixation system; consists of fixation components and implantable bone screws. Bone screws inserted through skin/soft tissue into bone; fixator frame attached to screw shanks. Used by surgeons for orthopedic stabilization. Provides mechanical support for bone healing/reconstruction. Modification adds a component to existing system; fundamental technology unchanged.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Unilateral external fixation device. Materials: Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, Titanium Alloy. Components provided non-sterile. Mechanical fixation via bone screw clamps.

Indications for Use

Indicated for patients requiring treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, and fracture fixation amenable to 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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K012024

# JUL 2 5 2001

### Special 510(k) Device Modification: EBI® XFIX® DFS® Fixation System

### 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is This Jro(k) Baniinary of Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

#### 1. Sponsor:

Contact Person: Patricia Flood, RAC [phone], ext.3318 Telephone:

EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Date Prepared: June 27, 2001

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

#### 3. Predicate or Legally Marketed Device:

EBI® XFIX® DFS® System (K953406) .

#### 4. Description of Device:

The System consists of 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 component to the System.

#### 5. 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.

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#### 6. Materials:

The components of the System may be manufactured from materials such as Aluminum. Stainless Steel, Cobalt Chrome, Carbon Fiber, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, with flowing lines extending from the bottom profile. The overall design is simple and conveys a sense of unity and service.

JUL 2 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K012024

Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulatory Class: II Product Code: KTT Dated: June 27, 2001 Received: June28, 2001

Dear Ms. Flood:

We have reviewed your Section 510(k) notification of intent to market the device referenced w one reveal your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energials, to regard ent date of the Medical Device Amendments, or to devices that prior to rial) 20, 1976, 1976, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costilons of the Act. The general controls provisions of the Act include requirements for annual provisions of the Pres. "Proces, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Femanel I pprovide can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moportunity also regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Patricia Flood, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to begin markening , one device to a legally marketed nouncation. The I Dri Imaling of succion 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 specific advice for your actic devices), please contact the Office of Compliance at additionally 807.10 for m True diagnessions on the promotion and advertising of your device, [phone]. Addinomary, 101 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranuming of Felection to president from the Division of Small mountation on your responsibility and its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Rtmhllulm fa

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

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510(k) Number (if known):

EBI® XFIX® DFS® System Device Name:

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)

KmnheeeMD

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative
Productrological Devices (Division of General, Teneral, Tel. Division of Neurological Division of Neurological (2 and Neurological Development

510(k) Numbe