CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003

K043583 · Wrightmedicaltechnologyinc · HWC · Jan 26, 2005 · Orthopedic

Device Facts

• Record ID: K043583
• Device Name: CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Jan 26, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - · Fixation of Small Bone Fragments - · Weil osteotomy - · Mono-cortical fixation - · Osteotomies and fractures fixation in the foot and hand

Device Story

The CHARLOTTE™ Snap-Off Screw is a metallic bone fixation fastener used by surgeons for bone fracture fixation and reconstruction in the foot and hand. The device features self-drilling and self-tapping distal threads to facilitate insertion into bone. It is intended to provide mechanical stability to bone fragments or osteotomy sites. The device is used in a clinical or surgical setting by a physician.

Clinical Evidence

Bench testing only; no clinical data provided. Testing performed in accordance with ASTM 543-02.

Technological Characteristics

Manufactured from ASTM F136 (Ti-6Al-4V ELI) titanium alloy. Features self-drilling and self-tapping distal threads. Available in one diameter and three lengths. Mechanical fixation device.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction in the foot and hand, including small bone fragments, Weil osteotomy, and mono-cortical fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Wright Pre-amendment No. 223 Knowles Pin

Submission Summary (Full Text)

{0}------------------------------------------------

K043583

### JAN 2 6 2005

## 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 CHARLOTTE™ High-Demand Compression Screw.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------|
| Date: | December 22, 2004 |
| Contact Person: | Wesley L. Reed<br>Regulatory Affairs Specialist |
| Proprietary Name: | CHARLOTTE™ Snap-Off Screw |
| Common Name: | Bone Fixation Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener - Class II |

## DEVICE INFORMATION

#### A. INTENDED USE

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- · Fixation of Small Bone Fragments
- · Weil osteotomy
- · Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand

## B. DEVICE DESCRIPTION

The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:

Screw

- . Manufactured from ASTM F136 (Ti-6A1-4V ELI)
- . Available in one diameter and three lengths
- Self drilling and self tapping features on distal threads .

{1}------------------------------------------------

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the Wright Pre-amendment No. 223 Knowles Pin. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ Snap-Off Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is rendered in black and white, and the text is also in black.

Public Health Service

JAN 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K043583

Trade/Device Name: CHROLOTTE™ Snap-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 27, 2004 Received: December 28, 2004

Dear Mr. Reed:

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.

{3}------------------------------------------------

Page 2 - Mr. Wesley L. Reed

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,

for Mark A. Millmann

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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name:_CHARLOTTE™ Snap-Off Screw

Indications For Use:

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- · Fixation of Small Bone Fragments
- · Weil osteotomy
- Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand

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)

O - Mark - 1 - Wilkinson

1 of 1

- Division of General, Restorative, and Neurological Devices
5190: Number

K043583