SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM

K040336 · Synthes (Usa) · HSB · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K040336
• Device Name: SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

Device Story

System consists of cannulated femoral nails, solid 6.5 mm recon locking screws, and cannulated end caps; used to stabilize femoral fractures. Device implanted by surgeons in clinical/OR settings. Nails and screws secure bone fragments to facilitate healing; titanium alloy construction. Output is physical stabilization of bone; clinical decision-making based on radiographic assessment of fracture type and patient anatomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy intramedullary fixation system. Components include cannulated femoral nails, 6.5 mm solid recon locking screws, and cannulated end caps. Compatible with 5.0 mm and 6.0 mm locking screws. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for stabilization of femoral shaft, subtrochanteric, and ipsilateral neck/shaft fractures, as well as impending pathologic fractures, non-unions, and malunions in patients requiring intramedullary fixation.

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

• Synthes Ti Cannulated Femoral Nail
• Smith & Nephew TriGen Antegrade Femoral Nail
• DePuy ACE ART Femoral Nail

Submission Summary (Full Text)

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## APR 1 2 2004

:

040336
page 1 of 1

- 3. 510(k) Summary:

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes (USA) Lateral Entry Femoral Nail System |
| Device Classification: | 21 CFR 888.3020 -- "Intramedullary fixation rod"<br>21 CFR 888.3040 -- "Smooth or threaded metallic bone<br>fixation fastener" |
| Predicate Device: | Synthes Ti Cannulated Femoral Nail, Smith & Nephew TriGen<br>Antegrade Femoral Nail and DePuy ACE ART Femoral Nail. |
| Description of Device: | Synthes Lateral Entry Femoral Nail System is composed of<br>cannulated femoral nails, solid 6.5 mm recon locking screws and<br>cannulated end caps. Recon locking screws, as well as Synthes<br>commercially available 5.0 mm and 6.0 mm locking screws, are used<br>to secure the nail in the bone. |
| Indications: | Synthes Lateral Entry Femoral Nail System is intended to stabilize<br>femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft<br>fractures, impending pathologic fractures, non-unions and malunions. |
| Material: | Titanium alloy |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes<br>Lateral Entry Femoral Nail System is substantially equivalent* to<br>other legally marketed devices. |
| | * The term "substantially equivalent" as used in this 510(k) notification is<br>limited to the definition of substantial equivalence found in the Food, Drug,<br>and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,<br>under which a device can be marketed without pre-market approval or<br>reclassification. A determination of substantial equivalency under this<br>notification is not intended to have any bearing whatsoever on the resolution<br>of patent infringement suits or any other patent matter. No statements related<br>to, or in support of substantial equivalence herein shall be construed as an<br>admission against interest under the US Patent Laws or their application by the<br>courts. |

1000 - 1000

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CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, black silhouette.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301

Re: K040336

Trade/Device Name: Synthes (USA) Lateral Entry Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 10, 2004 Received: February 11, 2004

Dear Ms. Musgnung:

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 enclosurc) 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 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 -- Ms. Sheri L. Musgnung

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,

Mark A Milken

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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## 2. Indications for Use

Page of

510(k) Number (if known):

Device Name:

Indications for Use:

Synthes (USA) Lateral Entry Femoral Nail System

Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

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

K040336

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Mark A. Millerson

n of General, Restorative, and Neurological Devices

CONFIDENTIAL

510(k) Number K040336
0004

Premarket Notification 510(k) Synthes I ateral Entry Femoral Nail System