BONE FIXATION WIRE (KIRSCHNER WIRE)

K073674 · Signal Medical Corp. · HTY · Mar 24, 2008 · Orthopedic

Device Facts

• Record ID: K073674
• Device Name: BONE FIXATION WIRE (KIRSCHNER WIRE)
• Applicant: Signal Medical Corp.
• Product Code: HTY · Orthopedic
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The wires are intended for use in the fixation of bone fractures, for bone reconstruction, or as a guide/aid for the insertion of other medical devices.

Device Story

Bone Fixation Wire (Kirschner Wire) consists of stainless steel wires of varying lengths and diameters. Used by surgeons in clinical settings for bone fracture fixation, bone reconstruction, or as a guide for inserting other medical devices. Device provides mechanical stabilization or guidance during orthopedic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener (Kirschner wire) made of 316LVM stainless steel. Smooth or threaded design. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, or as a guide/aid for the insertion of other medical devices.

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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K073674
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MAR 2 4 2008

## 510(k) Summary

Submitted by: Signal Medical Corporation 400 Pyramid Drive Marysville, MI 48040

Class II, 888.3040- Smooth or threaded Classification name: Metallic bone fixation fastener

Common Name: Bone Fixation Fasteners

Substantial Equivalence: Documentation is provided that demonstrates the wires to be substantially equivalent to other legally marketed devices.

Device Description: The device consist of various diameter and length wires for use in the fixation of bone fractures, bone reconstruction, or as a quide or aide for insertion of other medical devices. The wires are made of 316LVM Stainless Steel.

Intended Use: The wires are intended for use in the fixation of bone fractures, for bone reconstruction, and as a guide for insertion of other medical devices.

Material: 316 Stainless Steel

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Signal Medical Corporation % Louis A. Serafin, Jr., M.D. 400 Pyramid Drive Marysville, MI 48040

MAR 2 4 2008

K073674 Trade/Device Name: Bone Fixation Wire (Kirschner Wire) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 12, 2008 Received: March 13, 2008

Dear Dr. Serafin:

Re:

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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Page 2 - Louis A. Serafin, Jr., M.D.

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. Mulhearn

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): K073674

Device Name: Bone Fixation Wire (Kirschner Wire)

Indications For Use:

The wires are intended for use in the fixation of bone fractures, for bone reconstruction, or as a guide/aid for the insertion of other medical devices.

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

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Joutus
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ivision of General, Restorative, and Neurological Devices

510(k) Number K073674