SYNTHES (USA) TIBIAL NAIL SYSTEM EX

K040762 · Synthes (Usa) · JDS · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K040762
• Device Name: SYNTHES (USA) TIBIAL NAIL SYSTEM EX
• Applicant: Synthes (Usa)
• Product Code: JDS · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Device Story

Synthes Tibial Nail System EX is an intramedullary fixation system for tibial fractures. System components include cannulated tibial nails, 5.0 mm dual core locking screws, and end caps. Device functions by securing nail within bone to prevent rotation and provide axial compression. Used by surgeons in clinical/OR settings to stabilize fractures, promoting healing and alignment. Benefits include mechanical stabilization of tibial bone segments.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Titanium alloy intramedullary nail system. Components include cannulated nails, 5.0 mm dual core locking screws, and end caps. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for stabilization of proximal, distal, and tibial shaft fractures, including open and closed shaft fractures, pre- and post-isthmic fractures, and tibial malunions and non-unions.

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

• Synthes Titanium Solid and Cannulated Tibial Nail

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. There is a registered trademark symbol after the word "SYNTHES".

APR 1 2 2004

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- 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) Tibial Nail System EX |
| 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 Titanium Solid and Cannulated Tibial Nail |
| Description of Device: | Synthes Tibial Nail System Ex is composed of cannulated tibial nails,<br>5.0 mm dual core locking screws and end caps. The 5.0 mm dual<br>core locking screws, end caps, and Synthes commercially available<br>locking screws and locking bolts are used to secure the nail in the<br>bone, preventing rotation and axial compression. |
| Indications: | Synthes Tibial Nail System Ex is intended to stabilize fractures of the<br>proximal and distal tibia and the tibial shaft; open and closed tibial<br>shaft fractures; certain pre- and post-isthmic fractures; and tibial<br>malunions and non-unions. |
| Material: | Titanium alloy |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes<br>Cannulated Tibial Nail System EX is substantially equivalent to other<br>legally marketed devices. |

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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 circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress.

Public Health Service

APR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K040762

Trade/Device Name: Synthes (USA) Tibial Nail System EX Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDS. Dated: March 24, 2004 Received: March 25, 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 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 adultcration.

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,

P. Mark A. Melkersen

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

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510(k) Number (if known):

K040762

Device Name:

Indications for Use:

Synthes (USA) Tibial Nail System EX

Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain preand post-isthmic fractures; and tibial malunions and non-unions.

Prescription Use X (Per 21 CFR 801:109) ાર

Over-The-Counter Use_

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

Concurrence of GDRH, Office of Device Faluation (ODE)

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Division Sign-Off

Melkers

Division of General, Restorative,

and Neurological Devices

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