CHARLOTTE HIGH-DEMAND COMPRESSION SCREW

K043281 · Wrightmedicaltechnologyinc · HWC · Jan 19, 2005 · Orthopedic

Device Facts

• Record ID: K043281
• Device Name: CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHARLOTTE™ High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: · Fixation of bone fragments, in long bones or small bones fractures · Fracture management in the foot or hand · Arthrodesis in hand, foot or ankle surgery · Mono or Bi-cortical osteotomies in the foot or hand or in long bones · Treatment of inferior tibio fibular diastasis · Hindfoot arthrodesis

Device Story

Bone fixation system; includes compression screws and caps. Screws feature self-drilling distal tip; self-tapping distal threads. Used by surgeons for fracture management; bone reconstruction; arthrodesis; osteotomies. Provides mechanical stabilization of bone fragments. Sold non-sterile; requires sterilization before use.

Clinical Evidence

Bench testing only; testing performed in accordance with ASTM 543-02.

Technological Characteristics

Metallic bone fixation fastener; stainless steel (ASTM F 138, cold worked). Features self-drilling/self-tapping distal end. Available in various lengths/thread lengths. Non-sterile.

Indications for Use

Indicated for patients requiring bone fracture fixation or reconstruction, including long and small bone fractures, foot/hand fracture management, arthrodesis (hand, foot, ankle, hindfoot), and mono/bi-cortical osteotomies.

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

• Newdeal I.CO.S.® Screw

Submission Summary (Full Text)

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## 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 use of the CHARLOTTE™ High-Demand Compression Screw.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------|
| Date: | November 24, 2004 |
| Contact Person: | Wesley L. Reed Regulatory Affairs Specialist |
| Proprietary Name: | CHARLOTTE™ High-Demand Compression<br>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™ High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis

### B. DEVICE DESCRIPTION

The design features of the CHARLOTTE™ High-Demand Compression Screw are summarized below:

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### Screws

- · Available in 1 diameter, 15 lengths, and 3 thread lengths.
- Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
- · The distal tip of the screw is to be self drilling.
- · The distal threaded portion is to be self tapping.
- · Packaged non-sterile and sold as a set in a suitable sterilization tray or individually.

#### Compression Caps

- · Available in one size.
- · Available with either a grooved or smooth outer surface.
- · Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ High-Demand Compression Screw are substantially equivalent to the previously cleared Newdeal I.CO.S.® Screw. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ High-Demand Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2005

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

Re: K043281

Trade/Device Name: CHARLOTTE™ High Demand Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: November 24, 2004 Received: November 26, 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 commence 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 – 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 other general s. 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,

Mark A. Millman

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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# Indications for Use

510(k) Number (if known):

Device Name: CHARLOTTE™ High Demand Compression Screw

Indications For Use:

The High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis

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)

1 of 1

Mark N. Melhusso

al. Restorative, and Neurological Devices

**510(k) Number** K043281