Kirschner Wires, Steinmann Pins

K143618 · Zimmer, Inc. · HTY · Feb 6, 2015 · Orthopedic

Device Facts

• Record ID: K143618
• Device Name: Kirschner Wires, Steinmann Pins
• Applicant: Zimmer, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded or unthreaded form depending upon the desired application.

Device Story

Zimmer Kirschner wires and Steinmann pins are metallic orthopedic fixation devices used for fracture stabilization and bone reconstruction. Available in various diameters, lengths, and threaded or smooth configurations; they function as guide pins for other implants or as percutaneous pins for skeletal traction. Used in clinical settings by orthopedic surgeons; devices provide mechanical stability to bone segments during healing. Benefit includes support for bone alignment and stabilization. Provided sterile or non-sterile.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data, including biocompatibility testing per ISO 10993-1 and mechanical property conformance to ASTM F366-10 and ISO 5838-1.

Technological Characteristics

Metallic bone fixation fasteners; available in smooth or threaded configurations. Conforms to ASTM F366-10 and ISO 5838-1 for dimensional and material mechanical properties. Biocompatibility verified per ISO 10993-1. Sterilization provided for sterile-labeled units.

Indications for Use

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

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

• Kirschner Medical Corp., Kirschner Wire and Steinman Pins (K831005)

Submission Summary (Full Text)

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February 6, 2015

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

Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. BOX 708 Warsaw, Indiana 46581

Re: K143618

Trade/Device Name: Zimmer 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: December 18, 2014 Received: December 19, 2014

Dear Mr. Stephen McKelvey:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Stephen H. McKelvey

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K143618

Device Name

Zimmer Kirschner wires and Steinmann pins

#### Indications for Use (Describe)

Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded form depending upon the desired application.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey<br>Senior Project Manager, Trauma Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 12/18/2014 |
| Trade Name: | Zimmer Kirschner Wires and Steinmann Pins, |
| Common Name: | Kirschner Wires and Steinmann Pins |
| Classification Names<br>and References: | Pin, Fixation, Smooth (HTY) and Pin, Fixation, Threaded<br>(JDW) - both per 21 § CFR 888.3040, Smooth or threaded<br>metallic bone fixation faster |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Kirschner Medical Corp., Kirschner Wire and Steinman<br>Pins (K831005 - cleared 05/18/1983) |
| Purpose and Device Description: | Zimmer Kirschner Wires and Steinmann Pins are used for<br>fracture stabilization during the healing process. These<br>wires are available in multiple diameters and lengths and<br>threaded/unthreaded (smooth) versions. |
| Intended Use: | Kirschner wires (K-Wires) and Steinmann pins are used<br>for fixation of bone fractures, bone reconstruction, as<br>guide pins for insertion of other implants, or to be<br>implanted through the skin so that traction may be applied<br>to the skeletal system. The pins and wires may be used in<br>the threaded or unthreaded form depending upon the<br>desired application. |

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| Comparison to Predicate Device: | The Zimmer Kirschner Wires and Steinmann Pins are<br>identical in intended use and similar in basic shape,<br>materials and performance characteristics to the predicate<br>devices. The subject devices are provided sterile or non-<br>sterile. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Biocompatibility - Biocompatibility testing on the<br>Pins and Wires materials was conducted per<br>ISO 10993-1 and Good Laboratory Practices<br>(21 CFR § 58). All testing passed. The Zimmer subject devices were considered for<br>conformance to dimensional and material mechanical<br>property standards ASTM F366 -10 and<br>ISO 5838-1. All items in the scope were in<br>conformance with those standards and are therefore |

Conclusions: The data presented in this submission demonstrates that the subject device is substantially equivalent to the predicate devices.

substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

- . Clinical data and conclusions were not needed for these devices.