EBI TROCHANTERIC NAIL SYSTEM

K050118 · Ebi, L.P. · HSB · Feb 16, 2005 · Orthopedic

Device Facts

• Record ID: K050118
• Device Name: EBI TROCHANTERIC NAIL SYSTEM
• Applicant: Ebi, L.P.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® Trochanteric Nail System is intended to be implanted into the long bones for alignment, stabilization, and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for athrodesis.

Device Story

The EBI Trochanteric Nail System is an interlocking intramedullary rod system used for femoral fracture fixation. Components include trochanteric nails, lag screws, cortical screws, end caps, and set screws. The device is implanted by surgeons in a clinical/OR setting to provide mechanical alignment and stabilization of long bones. It functions as an internal fixation device to support bone healing following trauma, disease, or surgical correction. The system is designed to be mechanically equivalent to existing intramedullary nail systems.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated the device is as strong as the predicate device.

Technological Characteristics

Intramedullary fixation rod system consisting of trochanteric nails, lag screws, cortical screws, end caps, and set screws. Mechanical design and materials are consistent with currently marketed internal fixation systems.

Indications for Use

Indicated for treatment of femoral fractures including non-comminuted and comminuted midshaft, subtrochanteric, distal third, combination shaft and neck, intertrochanteric, and combination intertrochanteric/subtrochanteric fractures. Also indicated for osteotomies, tumor resection reconstruction, revision procedures, and arthrodesis.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Biomet Holland Femoral Nail System (K983641)

Submission Summary (Full Text)

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K050118

FEB / 6 / JUS

## 510(k) Summary

This 510(k) Summary for the EBI® Trochanteric Nail 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: | Frederic Testa<br>Phone: [phone], ext. 2208 |
|-----------------------|--------------------------------------------------------------------|-----------------|---------------------------------------------------|
| Date prepared: | January 17, 2005 | | |
| 2. Proprietary Name: | EBI® Trochanteric Nail System | | |
| Common Name: | Internal Fixation Device | | |
| Classification Names: | Rod, Fixation, Intramedullary and Accessories,<br>21 CFR 888.3020. | | |

- 3. Predicate or legally marketed device that is substantially equivalent:
Biomet Holland Femoral Nail System (K983641)

- 4. Description of the device: The EB10 Trochanteric Nail System is an interlocking intramedullary rod used in the fixation of fractures of the femur. The system consists of five basic components; trochanteric nails, lag screws, cortical screws, end caps, and set screws.
- 5. Intended Use: The EBI® Trochanteric Nail System is intended to be implanted into the long bones for alignment, stabilization, and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for athrodesis.

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- 6. Non-Clinical Testing: The results of the mechanical testing demonstrate that the EBI Trochanteric Nail System is mechanically as strong as the predicate device.
- 7. Comparison of the technological characteristics of the device to predicate

devices: There are no significant differences between the EBI® Trochanteric Nail System and other currently marketed internal fixation systems. It is substantially equivalent* to the predicate device in regards to indications for use, location, design characteristics, material, mechanical strength, and sterility.

- 8. Conclusion: Technological characteristics and mechanical testing have demonstrated that the EBI Trochanteric Nail System is as safe and effective and performs as well as the predicate device and is therefore substantially equivalent.
^* 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.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

9200 C
Rockyv

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederic Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K050118

Trade/Device Name: EBI® Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: January 17, 2004 Received: January 18, 2004

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.

FEB 1 6 2005

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]. 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/industry/support/index.html.

Sincerely yours,

D Mark A. Milkerson

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

Page _ l __ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: EBI® Trochanteric Nail System

Indications For Use:

The EB1® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotomies, reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Millen

(Division Sign-Off)

Division of General, Restorative
and Neurological Services

510(k) Number KCS 011