MULTI-USE COMPRESSION SCREW

K043102 · Wrightmedicaltechnologyinc · HWC · Jan 21, 2005 · Orthopedic

Device Facts

• Record ID: K043102
• Device Name: MULTI-USE COMPRESSION SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Mono or Bi-Cortical osteotomies in the foot or hand -Distal or Proximal metatarsal or metacarpal osteotomies -Weil osteotomy -Fusion of the first metatarsophalangeal joint and interphalangeal joint -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) -Akin type osteotomy -Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus -Calcaneus/ cuboid arthrodesis -talar/ navicular arthrodesis

Device Story

Multi-Use Compression Screw is a metallic bone fixation fastener used by surgeons for bone fracture fixation or reconstruction in the foot or hand. The device features self-drilling and self-tapping threads on both distal and proximal ends; the proximal threaded head is designed to be fully recessed into bone to achieve a zero-profile fixation. It is available in 3.0mm and 4.3mm diameters and lengths from 10mm to 60mm. The screw provides mechanical stabilization of bone segments during healing.

Clinical Evidence

Bench testing only; testing performed in accordance with ASTM 543-02 to confirm substantial equivalence.

Technological Characteristics

Manufactured from stainless steel. Features self-drilling and self-tapping threads. Available in 3.0mm and 4.3mm diameters; 10mm-60mm lengths. Zero-profile design with fully recessed proximal head. Testing performed per ASTM 543-02.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies (e.g., Weil, Scarf, Chevron, Akin) and arthrodesis (e.g., metatarsophalangeal, interphalangeal, metatarsal-cuneiform, calcaneus-cuboid, talar-navicular).

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 BOLD® Compression Screw
• Newdeal I.CO.S.® Screw

Submission Summary (Full Text)

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

K043/02

#### JAN 2 1 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 use of the Multi-use Compression Screw.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------|
| Date: | November 4, 2004 |
| Contact Person: | Wesley L. Reed<br>Regulatory Affairs Specialist |
| Proprietary Name: | Multi-Use Compression 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 Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

-Mono or Bi-Cortical osteotomies in the foot or hand

-Distal or Proximal metatarsal or metacarpal osteotomies

-Weil osteotomy

-Fusion of the first metatarsophalangeal joint and interphalangeal joint

-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

-Akin type osteotomy

-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus

-Calcaneus/ cuboid arthrodesis

-talar/ navicular arthrodesis

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

### B. DEVICE DESCRIPTION

The design features of the Multi-Use Compression Screw are summarized below:

- Manufactured from Stainless Steel .
- Offered in two diameters: 3.0mm and 4.3mm .
- Offered in lengths ranging from 10mm-60mm .
- Offered in two thread lengths: short and long .
- Self drilling and self tapping features on both distal and proximal . threads
- Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the Multi-use Compression Screw are substantially equivalent to the previously cleared Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the Multi-use Compression 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2005

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

Re: K043102

Trade/Device Name: Multi-Use 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 5, 2004 Received: November 9, 2004

Dear Mr. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de rices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, dicrerere, market of the Act include requirements for annual registration, listing of general controls pro resuring 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 rr your device is elassified (overal controls. Existing major regulations affecting your device can may be our leases to cases as 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 r lease be act not a a determination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must of any I occur statutes and regisments, including, but not limited to: registration and listing (2 l 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) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification: "The PPF mailing of cation 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 If you desire specific advice ice your 240) 276-0115. Also, please note the regulation entitled, Connact the Ories of Come of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Millerson

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: Multi-Use Compression Screw

Indications For Use:

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

-Mono or Bi-Cortical osteotomies in the foot or hand

-Distal or Proximal metatarsal or metacarpal osteotomies

-Weil osteotomy

-Frsion of the first metatarsophalangeal joint and interphalangeal joint -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

-Akin type osteotomy

-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus

-Calcaneus/ cuboid arthrodesis

-talar/ navicular arthrodesis

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

Use
rt C)

No

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

Concurrence of CDRH, Office Division of General. Restorative, and Neurological Devices

510(k) Number K043102

1 of 1