EBI XFIX ACCESS PELVIC FIXATOR

K011697 · Ebi, L.P. · KTT · Jun 27, 2001 · Orthopedic

Device Facts

• Record ID: K011697
• Device Name: EBI XFIX ACCESS PELVIC FIXATOR
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 27, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices 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 for bone stabilization; consists of implantable bone screws and external frame. Bone screws inserted through skin/soft tissue into bone; fixator frame attached to screw shanks. Modification introduces carbon fiber bar to replace titanium bar. Used in clinical settings for orthopedic procedures; operated by physicians. Provides mechanical stabilization of bone segments to facilitate healing or correction of bone conditions. Benefits patient by enabling treatment of fractures, deformities, and other bone pathologies via external fixation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

External fixation system. Components manufactured from Ti-6Al-4V ELI, Aluminum, Stainless Steel, and Carbon Fiber. System comprises bone screws and external frame. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients requiring external fixation for bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other conditions amenable to external fixation modality.

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}------------------------------------------------

K011697

# JUN 2 7 2001

## 510(k) Summary of Safety & Effectiveness

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

- Submitter: EBI, L.P. 1. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Jon Caparotta, RAC Telephone: [phone]

Date prepared: May 31, 2001

- 2. Proprietary Name: Common Name: Classification Names:
EBI® XFIX® Access™ Pelvic Fixator External Fixation Device Single Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030.

- Predicate or legally marketed devices that are substantially equivalent: 3.
· EBI® XFIX® DFS® System - Electro-Biology, Inc.

- Description of the device: The EBI® XFIX® Access™ Pelvic Fixator has not changed 4. the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic Fixator 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® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.
- Intended Use: The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are ર. unilateral external fixation devices 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.
- Materials: The components of the system are manufactured from materials such as Ti-6A1-4V 6. ELI, Aluminum, Stainless Steel, and Carbon Fiber.

22

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

- Comparison of the technological characteristics of the device to predicate devices: There are 7. no significant differences between the EBI® XFIX® Access™ Pelvic Fixator m and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission of substantial equivalial equivalence to any of the product is not * Any statement made in conjunction with uns submitted without re-markt and to reclassified ion and is not intended only to relate to when the product on the research infringened fities one thit one (Establishment Registration intended to be interpreted as an admission of any outer type of evidence in packs and any works.
and Premarket Notification Procedures, Final Regulation, Preamble, August 23,

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 7 2001

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

Re: K011697

Trade Name: EBI XFIX Access Pelvic Fixator Regulation Number: 888.3030 Regulatory Class: II Product Codes: KTT Dated: May 31, 2001 Received: June 1, 2001

### Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally it (x) is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the cherosure) to device Amendments, or to devices that have been reclassified in enacificili dato of the Fredical Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general control provisions of the Act. The general therefore, market the do rece sacjes to quirements for annual registration, listing of devices, control provisions or the fire, 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 (1 Chiarket Approval), it they of Sale, Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially equirement, 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 mispections, the Food and Dation may result in regulatory action. In addition, FDA may publish comply with the Criti regular 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, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific as a vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The classicstions on the promotion and advertising of your device, (2017) 594-4639 f 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 Information on your responsionally tree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Michlberger

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 of 1

510(k) Number (if known):

Device Name: EBI® XFIX® Access ™ Pelvic Fixator

Indications For Use:

The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices 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 X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

tj

Psmhulelcoms for CAUI

(Division Sign-Off) (Division Bigger Crail, Restorative Divisiourological Devices

510(k) Number_401027