EBI XFIX OPTIROM KNEE FIXATOR

K031093 · Ebi, L.P. · KTT · Jul 10, 2003 · Orthopedic

Device Facts

• Record ID: K031093
• Device Name: EBI XFIX OPTIROM KNEE FIXATOR
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® XFIX® OptiROM® Knee Fixator 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 OptiROM Knee Fixator is a unilateral external fixation module used with the EBI XFIX DFS System. Device consists of external fixation frame components and implantable bone screws. Physician inserts bone screws through skin and soft tissue into bone; fixator frame attaches to screw shanks. Used for stabilization in leg lengthening, osteotomies, arthrodesis, and fracture fixation. Provides mechanical support for bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Unilateral external fixation device. Materials include titanium, stainless steel, aluminum, and Delrin®. Mechanical fixation principle. No software, electronics, or energy source.

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)

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

# JUL 1 0 2003

K031093
page 1 of 2

## 510(k) Summary

This 510(k) Summary for the EBI® OptiROM® Knee Fixator is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

1. Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Contact Person: Frederic Testa, RAC Phone: [phone], ext. 2208

April 3, 2003 Date prepared:

| 2. Proprietary Name: | EBI® XFIX® OptiROM® Knee Fixator |
|-----------------------|----------------------------------------------------------------------------------------------------|
| 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. (K953406) .
- 4. Description of the device: The EBI® XFIX® OptiROM® Knee Fixator is a module which is used in conjunction with the currently marketed EBI® XFIX® DFS® System. The EBI® XFIX® OptiROM Knee Fixator has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The 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 System is attached to the shanks of the bone screws.

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

K031093
page 2 of 2

- 5. Intended Use: The EBI® XFIX® OptiROM® Knee Fixator 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, aluminum, and Delrin®.
- 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® XFIX® OptiROM® Knee Fixator and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent* to the predicate device 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 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 is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The logo is a stylized image of an eagle with three stripes across its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2003

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

Re: K031093

Trade/Device Name: EBI XFIX OptiROM Knee Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 3, 2003 Received: April 7, 2003

Dear Mr. Caparotta:

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

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

#### Page 2 - Mr. Jon Caparotta, RAC

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. 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

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

Page 1 of _ l

510(k) Number (if known): KO31C 93

Device Name: EBI® XFIX® OptiROM® Knee Fixator

Indications For Use:

The EBI® XFIX® OptiROM® Knee Fixator 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)

Muriam C. Provost

ivision of General. Restorative and Neurological Devices

510(k) Number K031093