PIN SCREW

K061599 · Bk Meditech, Co., Ltd. · JDW · Jul 26, 2006 · Orthopedic

Device Facts

• Record ID: K061599
• Device Name: PIN SCREW
• Applicant: Bk Meditech, Co., Ltd.
• Product Code: JDW · Orthopedic
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Device Story

Pin Screw is a metallic bone fixation fastener used for external skeletal fixation. Device consists of tapered, threaded pins available in various diameters and lengths with cortical or cancellous thread patterns; some models feature self-drilling tips. Operated by orthopedic surgeons in clinical or surgical settings, pins are inserted into bone near fracture sites and connected to a rigid external supporting frame to immobilize unstable or open fractures. This stabilization facilitates bone healing in patients where soft tissue damage prevents alternative treatments like casting or internal fixation. Device is provided non-sterile and requires cleaning and sterilization by the user prior to application.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: 316L stainless steel per ASTM F138. Design: Tapered thread diameter, cortical/cancellous patterns, optional self-drilling tips. Form factor: Fixation pin. Sterilization: Non-sterile, requires user-performed cleaning/sterilization.

Indications for Use

Indicated for patients with open or unstable fractures requiring immobilization via rigid external supporting frame, particularly when soft tissue injury precludes internal fixation, casting, or IM rodding.

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

• Apex Fixation Pins (K011136)

Submission Summary (Full Text)

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# K061599 (pg 1 of 2

# 510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

## Submission Information

| Sponsor: | BK MEDITECH Co., Ltd.<br>215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,<br>Kyunggi-Do, Republic of Korea |
|-------------------------|------------------------------------------------------------------------------------------------------|
| Manufacturing Site | BK MEDITECH Co., Ltd.<br>215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,<br>Kyunggi-Do, Republic of Korea |
| US Agent: | Henry Yang<br>25041, Farrier Circle, Laguna Hills, CA 92653 |
| Official Correspondent: | Byungjun Park<br>215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si,<br>Kyunggi-Do, Republic of Korea |

## Device Identification

| Proprietary Name: | Pin Screw |
|----------------------|-----------------------------------------------------------------------------|
| Common/Usual Name: | Fixation Pin |
| Classification Name: | Smooth or threaded metallic bone fixation fastener per 21<br>CFR § 888.3040 |
| Product Code: | JDW |

# Substantially Equivalent Predicate Legally Marketed Devices

The subject device, Pin Screw, is substantially equivalent in function, design, composition, material and intended used to: Apex Fixation Pins(K011136)

#### Device Description

The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads.

The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD.

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K061599 (pg 2 of 2)

#### ASTM F138.

The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures

The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.

### Indications for Use

The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

## Comparison to Legally Marketed Predicate Device

ﺮﻳﻌﻪ

The technological characteristics are the same as or equivalent to the predicate device previously listed.

Therewith, the Pin Screw is manufactured from 316L stainless steel which is identical to all of the identified predicate device.

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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 circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or extensions reaching upwards.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

BK Meditech Co., Ltd. % Mr. Byungjun Park Manager 215-5 Yodang-Li, Yanggam-Myun Hwasung-si, Kyunggi-do 445-931 Republic of Korea

Re: K061599

Trade/Device Name: Pin Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: June 5, 2006 Received: June 9, 2006

Dear Mr. Park:

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 complics 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 - Mr. Byungjun Park

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/cdrl/industry/support/index.html.

Sincerely yours,

Barbara Buell

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): KO6 1599

Device Name:

Pin Screw

Indications for Use:

The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Aertina, Brechus in myen

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) NumberK MEDITECH CO.,LTD.

Pin Screw