DARCO SMALL SCREW

K082320 · Wrightmedicaltechnologyinc · HWC · Nov 5, 2008 · Orthopedic

Device Facts

• Record ID: K082320
• Device Name: DARCO SMALL SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Nov 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WRIGHT™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Device Story

WRIGHT™ Compression Screws are metallic bone fixation fasteners used by orthopedic surgeons for bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair. The device consists of titanium alloy screws available in headed or headless configurations, in various diameters and lengths, and featuring a cannulated design. These screws are implanted during surgical procedures to provide mechanical stabilization of bone segments. By providing compression and fixation, the device facilitates bone healing and structural stability. The device is intended for single use only.

Clinical Evidence

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

Technological Characteristics

Manufactured from titanium alloy. Available in headed or headless configurations. Cannulated design. Various diameters and lengths. Class II medical device (21 CFR 888.3040).

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in patients requiring bone fixation appropriate for the device size. Single use only.

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)

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K0r2320

# NOV - 5 2008

## 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 DARCO® Small Screws.

| Submitted By: | Wright Medical Technology, Inc. |
|-----------------------------------|-----------------------------------------|
| Date: | August 11, 2008 |
| Contact Person: | Sarah Holtgrewe |
| | Regulatory Affairs Specialist |
| Proprietary Name: | WRIGHT™ Compression Screws |
| Common Name: | Bone Screws |
| Device Classification Regulation: | 21 CFR 888.3040--Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation, Bone/ Orthopedics |

### DEVICE INFORMATION

#### A. INTENDED USE

The WRIGHT™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

## B. DEVICE DESCRIPTION

The design features of the WRIGHT™ Compression Screws are described below.

- Manufactured from Titanium Alloy .
- Available headed or headless .
- Available in various diameters and lengths .
- . Cannulated

. . . . .

The design features of the WRIGHT™ Compression Screws are substantially equivalent to the design features of other devices previously cleared for market.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the WRIGHT™ Compression Screws are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the WRIGHT™ Compression Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

NOV - 5 2008

Re: K082320

Trade/Device Name: WRIGHT™ Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 11, 2008 Received: August 13. 2008

Dear Ms. Holtgrewe:

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. Iisting 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 - Ms. Sarah Holtgrewe

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 the reporting 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. Mullen

- Mark N. Melkerson 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: WRIGHT™ Compression Screws

Indications For Use:

The WRIGHT™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

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)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

**510(k) Number** 16082320

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