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.

Device Description

Zimmer Kirschner Wires and Steinmann Pins are used for fracture stabilization during the healing process. These wires are available in multiple diameters and lengths and threaded/unthreaded (smooth) versions.

AI/ML Overview

The provided document describes the Zimmer Kirschner Wires and Steinmann Pins and their substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and performance as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on standards/tests)	Reported Device Performance
Biocompatibility: Conformance to ISO 10993-1 and Good Laboratory Practices (21 CFR § 58)	All testing passed. (Device materials are biocompatible)
Material / Dimensional Properties: Conformance to ASTM F366-10 and ISO 5838-1 standards	All items in scope were in conformance with these standards.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The document refers to "the Pins and Wires materials" and "All items in the scope" for testing.
Data Provenance: Not explicitly stated, however, the testing was conducted per international and national standards (ISO 10993-1, ASTM F366-10, ISO 5838-1) and US Good Laboratory Practices (21 CFR § 58). This implies the testing was performed in a controlled laboratory environment. Retrospective or prospective nature is not applicable as this concerns physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission pertains to physical medical devices (wires and pins), not an AI/ML algorithm requiring expert ground truth for interpretation. The ground truth is objective measurement against specified standards.

4. Adjudication method for the test set

Not applicable. See point 3. Testing involves objective measurements and adherence to engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth for the performance testing was established by objective technical standards and material specifications. Specifically:
- Biocompatibility: Conformance to ISO 10993-1 and 21 CFR § 58.
- Material and Dimensional Properties: Conformance to ASTM F366-10 and ISO 5838-1.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three faces in profile, stacked on top of each other.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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

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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in lowercase blue letters, using a sans-serif font.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveySenior Project Manager, Trauma Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 371-8760
Date:	12/18/2014
Trade Name:	Zimmer Kirschner Wires and Steinmann Pins,
Common Name:	Kirschner Wires and Steinmann Pins
Classification Namesand References:	Pin, Fixation, Smooth (HTY) and Pin, Fixation, Threaded(JDW) - both per 21 § CFR 888.3040, Smooth or threadedmetallic bone fixation faster
Classification Panel:	Orthopedics/87
Predicate Device(s):	Kirschner Medical Corp., Kirschner Wire and SteinmanPins (K831005 - cleared 05/18/1983)
Purpose and Device Description:	Zimmer Kirschner Wires and Steinmann Pins are used forfracture stabilization during the healing process. Thesewires are available in multiple diameters and lengths andthreaded/unthreaded (smooth) versions.
Intended Use:	Kirschner wires (K-Wires) and Steinmann pins are usedfor fixation of bone fractures, bone reconstruction, asguide pins for insertion of other implants, or to beimplanted through the skin so that traction may be appliedto the skeletal system. The pins and wires may be used inthe threaded or unthreaded form depending upon thedesired application.

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Comparison to Predicate Device:	The Zimmer Kirschner Wires and Steinmann Pins areidentical in intended use and similar in basic shape,materials and performance characteristics to the predicatedevices. The subject devices are provided sterile or non-sterile.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	Biocompatibility - Biocompatibility testing on thePins and Wires materials was conducted perISO 10993-1 and Good Laboratory Practices(21 CFR § 58). All testing passed. The Zimmer subject devices were considered forconformance to dimensional and material mechanicalproperty standards ASTM F366 -10 andISO 5838-1. All items in the scope were inconformance 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.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.