SMITH & NEPHEW RAIL SYSTEM

K090926 · Smith & Nephew, Inc. · KTT · Jun 8, 2009 · Orthopedic

Device Facts

• Record ID: K090926
• Device Name: SMITH & NEPHEW RAIL SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities. Components in the Smith & Nephew Rail System are for single use only.

Device Story

Unilateral external fixation system; used in orthopedic surgery for bone management. System comprises rail segments, pins, clamps, and accessories; components assembled into customized frames to meet specific patient needs. Used for fracture fixation, distraction/compression, and deformity correction. Operated by surgeons in clinical settings. Provides mechanical stabilization of bone segments; facilitates bone healing and alignment. Single-use device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Unilateral external fixation system consisting of metallic rail segments, pins, clamps, and accessories. Designed for single-use. Mechanical fixation principle.

Indications for Use

Indicated for adult and pediatric patients requiring fracture fixation (open/closed), management of fractures/diseases resulting in joint contractures or loss of range of motion, fractures requiring distraction, pseudarthrosis of long bones, limb lengthening, infected fractures, non-unions, and correction of long bone deformities.

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

• Smith & Nephew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories (K994143)
• Taylor Spatial Frame External Fixation System (K970748)
• Heidelberg External Fixator (K970751)
• Jet-X Bar System Clamps, Bar and Posts MR Conditional (K072212)
• Hex-Fix Field External Fixator (K953397)

Submission Summary (Full Text)

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K090926b (pg. 1 of 1)

### 510(k) Summary of Safety and Effectiveness Smith & Nephew Rail System

| Submitted By: | Smith & Nephew, Inc.,<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------|
| Date: | March 30, 2009 |
| | JUN - 8 2009 |
| Contact Person: | Laura Sejnowski, Regulatory Affairs Specialist<br>Tel: [phone] Fax: [phone] |
| Proprietary Name: | Smith & Nephew Rail System |
| Common Name: | External Fixation System |
| Classification Name and Reference: | 21 CFR 888.3030, smooth or threaded metallic bone<br>fixation fastener, Class II |
| Device Classification for Predicate Devices: | 21 CFR 888.3030, smooth or threaded metallic bone<br>fixation fastener, Class II |
| Device Product Code and Panel Code: | Panel: Orthopedics / 87<br>Product Code: KTT |

#### Device Description:

Device Description.
Subject of this premarket notification is the Smith & Nephew Rail System. The Smith & Nephew Rail System Subject of the promation notified offers specially designed components used in the management of Is a unlateral extential inxanon system that enoric openally, orthopedic surgery. System lower extremly bone fraction and rooms, distraction/compression devices and associated accessories components include fail Sognions, pir dainter, al. Like the predicate devices listed below, the subject made lion and minute and components that can be used with the rail segments (or frame) to provide a device customized to meet specific patient needs.

#### Intended Use:

meetided boo.
The Smith & Nephew Rail System and components are intended to be used on adult or pediatric patients as The Smith and are intended to be used for fracture fixation (open and closed); fractures and disease which required and are intended to ontractures or loss of range of motion and fractures requiring distraction; generally may round in joint outling, infected fractures or non-unions; and correction of long bone podualitires. The Smith & Nephew Rail System and its components are for single use only.

### Technological Characteristics:

Technological online of the recomments similar to legally marketed devices listed below in that they share rine online a nople from Ran of each of the similar materials, and incorporate similar technological characteristics.

#### Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features and overall indications for use.

- Smith & Neohew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and . Accessories - K994143
- Taylor Spatial Frame External Fixation System K970748 .
- Heidelberg External Fixator K970751 .
- Jet-X Bar System Clamps, Bar and Posts MR Conditional K072212 .
- Hex-Fix Field External Fixator K953397 ●

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes, resembling birds in flight, arranged in a diagonal line.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2009

Smith & Nephew. Inc. c/o Ms. Laura Sejnowski 1450 Brooks Road Memphis, Tennessee 38116

Re: K090926

Trade/Device Name: Smith & Nephew Rail System

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and

accessories

Regulatory Class: Class II Product Code: KTT Dated: March 30, 2009 Received: April 2, 2009

Dear Ms. Sejnowski:

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); medical device reporting (reporting of medical

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# Page 2 - Ms. Laura Sejnowski

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Barbara Buchun

Mark N. Melkerson Director

Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Kogo926

# Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: Smith & Nephew Rail System

Indications for Use:

The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities.

Components in the Smith & Nephew Rail System are for single use only.

Prescription Use × (Part 21 CFR 801.109)

AND/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)

Aibara Smelld for

ion of Surgical, Orthopedic,

510(k) Number K090226