5TH METATARSAL FRACTURE SCREW

K053136 · Wrightmedicaltechnologyinc · HWC · Jan 5, 2006 · Orthopedic

Device Facts

• Record ID: K053136
• Device Name: 5TH METATARSAL FRACTURE SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Jan 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include: - Fixation of malunions and nonunions - · Acute fractures - · Avulsion fractures - · Repetitive stress fractures - · Jones Fractures - · Malleolar Fractures - · Talus Fractures - · Greater Tuberosity Fractures

Device Story

Bone fixation screw used for orthopedic surgical procedures. Device provides mechanical stabilization of bone fractures or reconstruction sites in the 5th Metatarsal. Implanted by surgeons in clinical/OR settings. Provides rigid fixation to facilitate bone healing and patient recovery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manufactured from stainless steel. Offered in diameters of 4.5mm, 5.5mm, and 6.5mm with lengths ranging from 40mm-70mm. Mechanical bone fixation fastener.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction of the 5th Metatarsal, including malunions, nonunions, acute, avulsion, repetitive stress, Jones, malleolar, talus, and greater tuberosity fractures.

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

• Multi-Use Compression 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 5th Metatarsal Fracture Screw.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------|
| Date: | November 5, 2005 |
| Contact Person: | Wesley L. Reed |
| | Regulatory Affairs Specialist |
| Proprietary Name: | 5 ^th Metatarsal Fracture 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: | Orthopedics/87/HWC |

## DEVICE INFORMATION

### A. INTENDED USE

The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:

- Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- · Malleolar Fractures
- · Talus Fractures
- · Greater Tuberosity Fractures

#### B. DEVICE DESCRIPTION

The design features of the 5th Metatarsal Fracture Screw are summarized below:

- Manufactured from Stainless Steel .
- Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm .
- Offered in lengths ranging from 40mm-70mm .

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## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the 5" Metatarsal Fracture Screw are substantially equivalent to the previously cleared Multi-Use Compression Screw. The safety and effectiveness of the 5th Metatarsal Fracture Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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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, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three wavy lines that form a stylized human figure. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES" in a circular arrangement.

2006 JAN 5

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: K053136

> Trade/Device Name: 5th Metatarsal Fracture Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 4, 2005 Received: November 9, 2005

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.

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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,

Mark N. Melkerson

Acting 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

105 3136 510(k) Number (if known):

Device Name: 5th Metatarsal Fracture Screw

Indications For Use:

The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:

- Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- Malleolar Fractures
- · Talus Fractures
- · Greater Tuberosity Fractures

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K053136 |
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