DSI PINS AND WIRES

K060654 · Delta Surgical Instruments, Inc. · HTY · Apr 28, 2006 · Orthopedic

Device Facts

• Record ID: K060654
• Device Name: DSI PINS AND WIRES
• Applicant: Delta Surgical Instruments, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.

Device Story

DSI Pins and Wires consist of Kirschner wires, Steinmann pins, and cerclage wires. Used by surgeons for bone fracture fixation, bone reconstruction, or as guides for other medical devices. Manufactured from 316 implant-grade stainless steel. Marketed non-sterile for single-use. Device provides mechanical stabilization of bone segments or serves as a surgical aid during orthopedic procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: 316 implant-grade stainless steel. Form factor: Pins and wires (Kirschner, Steinmann, Cerclage). Non-sterile, single-use. Mechanical fixation device.

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, or as a guide/aid for the insertion of other medical devices. Single-use, non-sterile device.

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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K060654

## 510(k) Summary

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| Submitted by: | Delta Surgical Instruments, Inc.<br>95 Schunnemunk Road<br>Highland Mills, NY 10930 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dandenia Zabat<br>Quality Assurance / Regulatory Manager<br>845-928-3760 |
| Date prepared: | March 10, 2006 |
| Classification Name: | Class II, 888.3040 - Smooth or Threaded Metallic Bone<br>Fixation Fasteners |
| Common Name: | Bone Fixation Devices |
| Proprietary Name: | DSI Pins and Wires |
| Substantial Equivalence: | Comparative information presented supports substantial<br>equivalence. |
| Description: | DSI Pins and Wires consist of various pins and wires for<br>use in the fixation of bone fractures, bone reconstruction, or<br>as a guide/aid for insertion of other medical devices. All<br>DSI Pins and Wires included in this submission are<br>manufactured of implant grade stainless steel. All DSI Pins<br>and Wires included in this submission will be marketed<br>non-sterile. Kirschner Wires, Steinmann Pins and Cerclage<br>Wires are included in this submission. |
| Intended Use: | DSI Pins and Wires are non-sterile, single-use pins and<br>wires intended to be used for the fixation of bone fractures,<br>bone reconstruction, or as a guide/aid for the insertion of<br>other medical devices. |
| Materials: | 316 implant grade stainless steel |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

200 2 8 2005

Delta Surgical Instruments, Inc. c/o Ms. Dandenia Zabat Quality Assurance/Regulatory Manager 95 Schunnemunk Road Highland Mills, New York 10930

Re: K060654

Trade/Device Name: DSI Pins and Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, JDW Dated: March 10, 2006 Received: March 16, 2006

Dear Ms. Zabat:

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

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Page 2 - Ms. Dandenia Zabat

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. 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/dsma/dsmamain.html

Sincerely yours.

Neil R.P. Ogden

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

<060654 510(k) Number (if known):

Device Name: D DSI Pins and Wires

Indications for Use:

DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.

Prescription Use X (Part 21 CFR 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)

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Neil
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K660654 510(k) Number