EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM

K001358 · Ebi, L.P. · KTT · May 23, 2000 · Orthopedic

Device Facts

• Record ID: K001358
• Device Name: EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: May 23, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI XFIX® DFS® Metaphyseal Correction 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

EBI XFIX® DFS® Metaphyseal Correction System is a unilateral external fixation device. System consists of external fixation components and implantable bone screws. Operation involves inserting bone screws through skin and soft tissue into bone; attaching fixator frame to screw shanks. Used by surgeons in clinical settings to stabilize bone segments for conditions like fractures, osteotomies, or leg lengthening. Provides mechanical stabilization to facilitate bone healing or correction. No software or electronic components involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Unilateral external fixation device. Materials: titanium, stainless steel, aluminum. Mechanical fixation principle. No energy source, software, or connectivity.

Indications for Use

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

Submission Summary (Full Text)

{0}------------------------------------------------

K001358

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

This 510(k) Summary of Safety and Effectiveness for the EBI XFIX® DFS® Metaphyseal Correction 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: Jon Caparotta<br>Telephone: [phone] |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Date prepared: April 27, 2000 | |
| 2. Proprietary Name: | EBI XFIX® DFS® Metaphyseal Correction<br>System |
| Common Name: | External Fixation Device |
| Classification Names: | Single/Multiple Component Metallic Bone<br>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. �
- 4. Description of the device: The EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction 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® Metaphyseal Correction System is

{1}------------------------------------------------

attached to the shanks of the bone screws. This submission is for additional components.

- 5. Intended Use: The EBI XFIX® DFS® Metaphyseal Correction 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.
- 6. Materials: The components of the System may be manufactured from materials such as titanium, stainless steel, and aluminum.
- 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction 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 approval or reclassification and is not intended to be 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.)]

{2}------------------------------------------------

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 3 2000

Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079

Re: K001358

Trade Name: EBI XFIX® DFS® Metaphyseal Correction System Regulatory Class: II Product Code: KTT Dated: April 27, 2000 Received: April 28, 2000

Dear Mr. Caparotta:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP 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.

This letter will allow you to begin marketing your device as described in your 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.

{3}------------------------------------------------

Page 2 - Mr. Jon Caparotta

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dona R. Lochner

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

{4}------------------------------------------------

## STATEMENT OF INDICATIONS FOR USE

#### 1_of_1 Page

510(k) Number (if known): との01ろ58

Device Name: EBI XFIX® DFS® Metaphyseal Correction System

Indications For Use:

The EBI XFIX® DFS® Metaphyseal Correction 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)

Dune R. Lochner

vision Sign-Off Division of General Restorative Devices 510(k) Number K 001358

G

: