The Zimmer® Periarticular Plating System - Screws are similar in intended use, type of materials, and performance characteristics to the predicate devices (Zimmer Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs. non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer® Periarticular Plating System - Screws. This document focuses on the non-clinical performance and substantial equivalence to predicate devices, rather than a study with a test set, experts, or ground truth as would be typical for an AI/ML medical device.

Therefore, many of the requested fields are not applicable to this type of regulatory submission. The device described is a physical surgical screw, not a software algorithm or an AI-enabled device.

I will fill in the available information and explicitly state when a requested field is not applicable based on the provided text.

Acceptance Criteria and Device Performance for Zimmer® Periarticular Plating System - Screws

Acceptance Criteria	Reported Device Performance
Material Properties:	Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, bending or fatigue failure, material strength.
Sterilization Validation:	To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6.
Shelf Life:	Accelerated aging showed that the product has a shelf life of 10 years.
Sterile Packaging:	To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
Mechanical Performance/Durability:	Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure. The new sterile screws are similar in intended use, type of materials, and performance characteristics to the predicate devices.

Study Details:

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This submission is for a physical medical device (screws) and relies on non-clinical (lab) performance testing and engineering evaluations, not a "test set" of data in the context of an AI/ML device. The various tests (biocompatibility, sterilization, shelf life, mechanical testing) would have involved a sufficient number of samples for those specific tests.
- Data Provenance: Not applicable. This refers to laboratory testing and engineering evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for the non-clinical testing of a physical device. Testing was conducted by qualified personnel in laboratories following established standards and good laboratory practices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's non-clinical performance evaluation.
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 a physical orthopedic screw, not an AI/ML diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical orthopedic screw, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on established engineering principles, material science standards (e.g., ISO 10993-1), and regulatory requirements (e.g., sterilization to a SAL ≥ 10^-6, accelerated aging for shelf life, mechanical properties testing). These are objective measurements and validations, not expert consensus on qualitative data.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable.

Summary

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KIII447(1/2)

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P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131

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510(k) Summary

Warsaw. IN 46581-0708

Zimmer, Inc.

P.O. Box 708

August 22, 2011

CFR 888.3040

non-sterile.

Sponsor:

Contact Person:

Stephen H. McKelvey Senior Project Manager. Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760

Zimmer® Periarticular Plating System - Screws

Zimmer Periarticular Locking Plate System

Smooth or threaded metallic bone fixation fastener - 21

Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

The Zimmer® Periarticular Plating System - Screws are

Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs.

characteristics to the predicate devices (Zimmer

Non-Clinical Performance and Conclusions:

similar in intended use, type of materials, and performance

Temporary Internal Fixation Devices

Date:

Trade Name:

Common Name:

Classification Names and References:

Predicate Devices:

Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

. Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6.

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KI11447 (2/2

. Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
. Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
. Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.

Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.

The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, bending or fatigue failure, material strength and the elimination of locking threads on the drive heads. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.

In summary, the sterile devices described in this submission are substantially equivalent to their predicates.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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

Zimmer. Inc. % Mr. Stephen McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

OCT - 5 2011

Re: K111447

Trade/Device Name: Zimmer® Periarticular Plating System - Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 22, 2011 Received: August 23, 2011

Dear Mr. 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 (reporting of medical

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Page 2 - Mr. Stephen McKelvey

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 Biometries/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkers 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

510(k) Number (if known): K1|||447

Device Name:

Zimmer® Periarticular Plating System - Screws

Indications for Use:

Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Alves to MX
(Division Sign-Off)

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

510(k) Number K111947

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.