APEX KIRSCHNER WIRES AND STEINMANN PINS

K112254 · Apex Tools & Orthopedics Co. · HTY · Oct 11, 2011 · Orthopedic

Device Facts

• Record ID: K112254
• Device Name: APEX KIRSCHNER WIRES AND STEINMANN PINS
• Applicant: Apex Tools & Orthopedics Co.
• Product Code: HTY · Orthopedic
• Decision Date: Oct 11, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 bone fixation fasteners used in orthopedic procedures. Available in various diameters, lengths, and point geometries, they are provided in both threaded and non-threaded designs. These devices are used by surgeons to stabilize bone fractures, facilitate bone reconstructions, serve as guide pins for other implants, or provide skeletal traction. They are implanted through the skin or directly into bone to provide mechanical support. The device functions as a passive mechanical implant; it does not involve electronic processing, software, or AI. Clinical benefit is derived from the mechanical fixation of bone segments to promote healing or alignment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation fasteners (smooth or threaded). Available in multiple diameters and lengths with various point geometries. Passive mechanical device. No energy source, software, or connectivity.

Indications for Use

Indicated for fixation of bone fractures, bone reconstructions, as guide pins for other implants, or for skeletal traction in patients requiring orthopedic stabilization.

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

• Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215)
• DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385)
• OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555)
• Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912)

Submission Summary (Full Text)

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# K112254(1/2)

OCT | 1 2011

#### 510(k) Summary 5.

| 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: | August 4, 2011 |
| Classifications: | 21 CFR 888.3040, Smooth or threaded metallic bone<br>fixation fasteners. |
| Class: | II |
| Product Codes: | HTY and IDW |

### 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.

### Substantial Equivalence

The Apex Kirschner Wires and Steinmann Pins are substantially equivalent to the following devices: Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215); DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385); OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555); Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912); with respect to indications, materials, and technological characteristics.

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# K112254(z/z)

## Preclinical Testing:

The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters.

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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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.

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

Apex Tools & Orthopedies Co. % Mr. Scott Liang General Manager 25 Yonghua, Yonghe, GETDD Guangzhou, Guangdong CN-511356 CHINA

00T 1 1 2011

Re: K112254

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: August 4, 2011 · Received: August 5, 2011

Dear Mr. Liang:

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 markcted 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 additional controls. Existing major regulations affecting your device (11 he 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 not me 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

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## Page 2 - Mr. Scott Liang

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.

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/Safetv/ReportalProblem/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.gov/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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#### Indications for Use 4.

510(k) Number (if known): K112254

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 1/ (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, Offige of Device Avaluation (ODE)

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

510(k) Number K11225.4