DARCO HEADLESS COMPRESSION SCREW

K080850 · Wrightmedicaltechnologyinc · HWC · Apr 10, 2008 · Orthopedic

Device Facts

• Record ID: K080850
• Device Name: DARCO HEADLESS COMPRESSION SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 7.0mm DARCO® Headless 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 The 4.3mm DARCO® Headless 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

DARCO Headless Compression Screw is a metallic bone fixation fastener used by orthopedic surgeons for fracture management, osteotomies, and arthrodesis in the foot, hand, and long bones. The device provides internal compression across bone fragments to facilitate healing and stabilization. It is implanted surgically; the surgeon selects appropriate screw lengths and thread configurations based on patient anatomy. The device remains in the body to maintain bone alignment during the healing process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material analysis.

Technological Characteristics

Manufactured from Titanium Alloy (ASTM F136). Headless, threaded bone fixation fastener design. Available in 7.0mm and 4.3mm diameters with varying lengths. Mechanical fixation device.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction in patients requiring orthopedic intervention in the foot, hand, or long bones, including osteotomies, arthrodesis, and fracture management.

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.

Submission Summary (Full Text)

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

K080850 pg lot 2

#### 510(K) SUMMARY APR 1 0 2008 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 DARCO® Headless Compression Screw.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------|
| Date: | February 28, 2008 |
| Contact Person: | Theresa Leister |
| | Senior Regulatory Affairs Specialist |
| Proprietary Name: | DARCO® Headless Compression Screw |
| Common Name: | Compression Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HWC |

## DEVICE INFORMATION

## A. INTENDED USE

The 7.0mm DARCO® Headless 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

The 4.3mm DARCO® Headless 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

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

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

- · Calcaneus/ cuboid arthrodesis
- · Talar/ navicular arthrodesis

# B. DEVICE DESCRIPTION

The DARCO® Headless Compression Screw is manufactured from Titanium Alloy conforming to ASTM F136. The screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the DARCO® Headless Compression Screw are substantially equivalent to previously cleared predicate device. The safety and effectiveness of the DARCO® Headless Compression Screw is adequately supported by the substantial equivalence information, matcrials 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Theresa Leister 5677 Airline Road Arlington, TN 38002

APR 1 0 2008

Re: K080850 Trade/Device Name: DARCO Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 28, 2008 Received: March 26, 2008

Dear Ms. Leister:

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 - Ms. Theresa Leister

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Wilkerson

Mark N. Melkerson 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: DARCO® Headless Compression Screw

Indications For Use:

The 7.0mm DARCO® Headless 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
- t Hindfoot arthrodesis

The 4.3mm DARCO® Headless 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 .

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 G e Evaluation (ODE)

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

510(k) Number K080850

1 of 1