RADIAL NAIL SYSTEM

K040938 · Wrightmedicaltechnologyinc · HRS · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K040938
• Device Name: RADIAL NAIL SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: - Joint destruction and/or subluxation visible on x-ray; - Failed fracture fixation with or without bone graft: ● - Osteotomy and repair of distal radius malunion with or without bone graft; . - Displaced or non-displaced fracture which may or may not involve angulation or fragmentation . of bone; - Comminuted articular fractures, shearing fractures of the articular surface, severely . comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Device Story

Radial Nail System; orthopedic bone fixation hardware for distal radius fractures. Components include radial nail, cortical bone screws, buttress pins, and buttress screws. Used by surgeons in clinical settings for internal fixation of unstable fractures where closed reduction fails. Provides mechanical stabilization of bone fragments to facilitate healing. Color-anodized components assist in size identification and differentiation during surgical implantation. Device is purely mechanical; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system consisting of a radial nail, cortical bone screws, and buttress pins/screws. Components are color-anodized for size identification. Mechanical fixation device; no energy source, connectivity, or software.

Indications for Use

Indicated for fixation of unstable distal radius fractures in patients where closed reduction is unsuitable, including cases of joint destruction/subluxation, failed prior fixation, malunion requiring osteotomy, displaced/non-displaced fractures with/without angulation or fragmentation, comminuted articular/extra-articular fractures, and loss of reduction following percutaneous pinning.

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

• LOCON-T® Distal Radial Plating System

Submission Summary (Full Text)

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040938

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Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three horizontal lines that are angled downwards and to the right, creating a stylized design element. The letters are all capitalized and the word is followed by a period. Below the lines, there is a small "TM" symbol, indicating a trademark.

JUL 01 2004

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the Radial Nail System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------|
| Date: | April 9, 2004 |
| Contact Person: | Ehab M Esmail |
| | Sr. Manager, Regulatory Affairs |
| Proprietary Name: | Radial Nail System |
| Common Name: | Radial Nail |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3030 Plate, Fixation, Bone - Class II |

## DEVICE INFORMATION

#### INTENDED USES/ INDICATIONS A.

The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray;
- Failed fracture fixation with or without bone graft: ●
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or fragmentation . of bone;
- Comminuted articular fractures, shearing fractures of the articular surface, severely . comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

#### DEVICE DESCRIPTION B.

The Radial Nail System consists of the following components: Radial Nail, Cortical Bone Screws, Buttress Pins and Screws. The design features of the components included in the Radial Nail System are summarized below:

**I Technology, Inc.** 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

ww.wmt.com

011.32.2.378.3905 Belo 011.39.0250.678.227 Ital

905.826.1600 Canada
011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France
011.44.1483.721.404 UK

011.49.4161.745130 Germany

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K040938 Pg 2/2

## Radial Nail

- · Universal in configuration no lefts or rights
- · Available in sizes 1-4
- · Color anodized to match instrumentation for easy size identification

## 2.7 mm Cortical Bone Screws

- · Lengths available: 12, 14, 16, 18, 20mm
- Color anodized to differentiate from 2.2mm buttress pins and 2.7mm buttress screws

## 2.2mm Buttress Pins

- · Lengths available: 20, 22, 24, 26, 28, 30mm
- Color anodized to differentiate from 2.7mm cortical screws and 2.7mm buttress screws

## 2.7mm Buttress Screws

- · Lengths available: 20, 22, 24, 26, 28, 30mm
- · Color anodized to differentiate from 2.7mm cortical screws and 2.2mm buttress pins

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indication for use of the Radial Nail System is substantially equivalent to the previously submitted and cleared LOCON-T® Distal Radial Plating System. The safety and effectiveness of the Radial Nail System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design consisting of three horizontal lines that converge to form a "W" shape. The letters "TM" are located at the bottom right corner of the design.

# Radial Nail System

# INDICATIONS STATEMENT

The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- . Joint destruction and/or subluxation visible on x-ray;
- . Failed fracture fixation with or without bone graft;
- . Osteotomy and repair of distal radius malunion with or without bone graft;
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- . Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

5677 Airline Road

901.867.9971 phone

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

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Image /page/3/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 an abstract image of an eagle or bird-like figure, with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 1 2004

Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technologies, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K040938

Trade/Device Name: Radial Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 9, 2004 Received: April 12, 2004

Dear Mr. Esmail:

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); 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 - Ehab M. Esmail

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.

Miriam C. Provost

Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K040938

Device Name: Radial Nail System

Indications For Use:

The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- . Joint destruction and/or subluxation visible on x-ray;
- Failed fracture fixation with or without bone graft;
- . Osteotomy and repair of distal radius malunion with or without bone graft;
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- . Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ K040938