APEX KIRSCHNER WIRES AND STEINMANN PINS

K121004 · Apex Tools & Orthopedics Co. · HTY · Apr 24, 2012 · Orthopedic

Device Facts

• Record ID: K121004
• Device Name: APEX KIRSCHNER WIRES AND STEINMANN PINS
• Applicant: Apex Tools & Orthopedics Co.
• Product Code: HTY · Orthopedic
• Decision Date: Apr 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Device Story

Apex Kirschner Wires and Steinmann Pins are metallic orthopedic fixation devices. Available in various diameters, lengths, threaded/non-threaded designs, and point geometries. Used by surgeons in clinical/OR settings for bone fracture fixation, bone reconstruction, as guide pins for other implants, or for skeletal traction. Device is implanted into bone. Provides mechanical stabilization of bone segments. No software or electronic components.

Clinical Evidence

Bench testing only; sterility validation study performed to confirm SAL of 10^-6 for non-sterile configuration.

Technological Characteristics

Metallic bone fixation fasteners; available in various diameters, lengths, threaded/non-threaded designs, and point geometries. No software or electronic components.

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, guide pins for implant insertion, or skeletal traction via percutaneous implantation.

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 Kirschner Wires and Steinmann Pins (K112254)

Submission Summary (Full Text)

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K121004

APR 2 4 2012

#### 5. 510(k) Summary

| Device Trade Name: | Apex Kirschner Wires and Steinmann Pins |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Apex Tools & Orthopedics Co. |
| Contact: | Apex Tools & Orthopedics Co.<br>25 Yonghua, Yonghe, GETDD<br>Guangzhou, Guangdong,<br>CN-511356<br>CHINA<br>Phone: [phone]<br>Fax: [phone] |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 2, 2012 |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HTY and IDW |

## Reason for Special 510(k) Submission:

The purpose of this 510(k) is to provide the Apex Kirschner Wires and Steinmann Pins in "non-sterile" form as well as the previously cleared "sterile" form. There have been no changes to the intended use of the device or its fundamental scientific technology.

### Indications For Use:

The Apex Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

### Device Description:

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

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K121004

# Predicate Devices:

The modified Apex Kirschner Wires and Steinmann Pins are substantially equivalent to the predicate Apex Kirschner Wires and Steinmann Pins (K112254) with respect to indications, design, function, materials, and sterility assurance level.

# Substantial Equivalence:

The Apex Kirschner Wires and Steinmann Pins are substantially equivalent to predicate devices with respect to indications, materials, and technological characteristics. To support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins, a sterility validation study was performed to confirm that a sterility assurance level (SAL) of 10 € was achieved with the recommended sterilization instructions.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines representing the body and wings of the bird.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Apex Tools & Orthopedics Company % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Hollace Saas Rhodes 1331 H Street, Northwest 12th Floor Washington, District of Columbia 20005

APR 2 4 2012

## Re: K121004

Trade/Device Name: Apex Kirschner Wires and Steinmann Pins Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: April 2, 2012 Received: April 6, 2012

#### Dear Ms. Rhodes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Hollace Saas Rhodes

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K121004

#### Indications for Use 4.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Apex Kirschner Wires and Steinmann Pins

The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Oft) -Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number C121004